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 | K834532 |
510k Number | K834532 |
Device Name: | STERILE WET DRESSING PACK |
Classification | Dressing, Wound, Drug |
Applicant | W.G. WHITNEY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-21 |
Decision Date | 1984-01-25 |