The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Suction Sponge.
| Device ID | K972634 |
| 510k Number | K972634 |
| Device Name: | ULTRACELL SUCTION SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK North Stonington, CT 06359 |
| Contact | George P Korteweg |
| Correspondent | George P Korteweg ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK North Stonington, CT 06359 |
| Product Code | GDY |
| Subsequent Product Code | HBA |
| Subsequent Product Code | HOZ |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-12-17 |