The following data is part of a premarket notification filed by 3m Company with the FDA for Closed Wound Vacuum Drainage System.
Device ID | K790654 |
510k Number | K790654 |
Device Name: | CLOSED WOUND VACUUM DRAINAGE SYSTEM |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-05 |
Decision Date | 1979-04-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M66536453 | K790654 | 000 |
M66536023 | K790654 | 000 |
M66536033 | K790654 | 000 |
M66536213 | K790654 | 000 |
M66536263 | K790654 | 000 |
M66536313 | K790654 | 000 |
M66536403 | K790654 | 000 |
M66536413 | K790654 | 000 |
M66536423 | K790654 | 000 |
M66536433 | K790654 | 000 |
M66536013 | K790654 | 000 |