The following data is part of a premarket notification filed by Belmac Healthcare Corp. with the FDA for Dispose-a-sheet.
| Device ID | K933636 |
| 510k Number | K933636 |
| Device Name: | DISPOSE-A-SHEET |
| Classification | Bedding, Disposable, Medical |
| Applicant | BELMAC HEALTHCARE CORP. ONE URBAN CENTER, SUITE 550 4830 W. KENNEDY BOULEVARD Tampa, FL 33609 |
| Contact | Damon Dale Phelps |
| Correspondent | Damon Dale Phelps BELMAC HEALTHCARE CORP. ONE URBAN CENTER, SUITE 550 4830 W. KENNEDY BOULEVARD Tampa, FL 33609 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1994-01-26 |