The following data is part of a premarket notification filed by Scivolutions, Inc. with the FDA for Doctors Choice Slow Healing Bandage With Spray On Remover.
| Device ID | K082208 |
| 510k Number | K082208 |
| Device Name: | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER |
| Classification | Dressing, Wound, Hydrophilic |
| Applicant | SCIVOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward SCIVOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | NAC |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-05 |
| Decision Date | 2008-12-01 |
| Summary: | summary |