The following data is part of a premarket notification filed by Gainor Medical with the FDA for Skin Closure.
Device ID | K840945 |
510k Number | K840945 |
Device Name: | SKIN CLOSURE |
Classification | Strip, Adhesive, Closure, Skin |
Applicant | GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
Contact | Mark Gainor |
Correspondent | Mark Gainor GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
Product Code | FPX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-05 |
Decision Date | 1984-10-31 |