The following data is part of a premarket notification filed by Bellhouse Medical, Inc. with the FDA for Aqua-gard Waterproof Wound Patch.
| Device ID | K905022 |
| 510k Number | K905022 |
| Device Name: | AQUA-GARD WATERPROOF WOUND PATCH |
| Classification | Tape And Bandage, Adhesive |
| Applicant | BELLHOUSE MEDICAL, INC. 2933 MANNING AVENUE NORTH Lake Elmo, MN 55042 |
| Contact | Julia Lord |
| Correspondent | Julia Lord BELLHOUSE MEDICAL, INC. 2933 MANNING AVENUE NORTH Lake Elmo, MN 55042 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-02-11 |