The following data is part of a premarket notification filed by W.g. Whitney Corp. with the FDA for Xeroform Dressing.
Device ID | K813535 |
510k Number | K813535 |
Device Name: | XEROFORM DRESSING |
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 | 1981-12-17 |
Decision Date | 1982-02-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10665973017126 | K813535 | 000 |
10665973016747 | K813535 | 000 |
20665973016683 | K813535 | 000 |
10665973016679 | K813535 | 000 |
10665973016501 | K813535 | 000 |