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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387809077 | K801550 | 000 |
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| 50707387773965 | K801550 | 000 |