The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Sureseal Bandage.
| Device ID | K922441 |
| 510k Number | K922441 |
| Device Name: | SURESEAL BANDAGE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | GAINOR MEDICAL EUROPE, LTD. 310 HOLDEN SHORE SUTIE 240 Long Beach, CA 90802 |
| Contact | Gainor |
| Correspondent | Gainor GAINOR MEDICAL EUROPE, LTD. 310 HOLDEN SHORE SUTIE 240 Long Beach, CA 90802 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1993-08-10 |