The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Germicidal Surgical Incise Drape.
Device ID | K801550 |
510k Number | K801550 |
Device Name: | 3M GERMICIDAL SURGICAL INCISE DRAPE |
Classification | Drape, Surgical |
Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-03 |
Decision Date | 1981-09-17 |