The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Orthopedic Sponges.
| Device ID | K950370 |
| 510k Number | K950370 |
| Device Name: | ULTRACELL ORTHOPEDIC SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic, CT 06372 |
| Contact | George P Korteweg |
| Correspondent | George P Korteweg ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic, CT 06372 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-04-17 |