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mikepgator

07/26/24 3:42 PM

#177676 RE: HoneyBager #177672

You’re saying the 30 day window started on 6/28 but I’m saying it started sometime between 6/28 and 7/9, that is all I’m saying, and I am 100% not wrong. And I’m pretty sure you are not right.

If you look at the FDA website, it looks like there could even be something that needs to be physically mailed. (may or may not apply here, didn’t really look too much into this)

For most devices, you must mail the Company Cover Letter and valid eCopy to CDRH’s or CBER’s Document Control Center (DCC). The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application#addfor
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kayak_wench

07/26/24 3:48 PM

#177679 RE: HoneyBager #177672

The slide clearly stated the submitted on Jun 28 and it clearly stated that the FDA has received and accepted the submission. The slide does not clearly tell us the date it ‘received’ it. You can infer a date of Jun 28 but it is not stated as that. It isn’t a big deal if it isn’t that date from the information I found it should be that date or a day or two after.