The following data is part of a premarket notification filed by W.g. Whitney Corp. with the FDA for Sterile Wet Dressing Pack.
Device ID | K781322 |
510k Number | K781322 |
Device Name: | STERILE WET DRESSING PACK |
Classification | Gauze/sponge, Internal |
Applicant | W.G. WHITNEY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-31 |
Decision Date | 1978-08-17 |