The following data is part of a premarket notification filed by Gainor Medical with the FDA for Cloth-hypoallergenic.
| Device ID | K840947 |
| 510k Number | K840947 |
| Device Name: | CLOTH-HYPOALLERGENIC |
| Classification | Tape And Bandage, Adhesive |
| Applicant | GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
| Product Code | KGX |
| 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 | 1984-08-17 |