The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Suction Sponge.
| Device ID | K972635 |
| 510k Number | K972635 |
| Device Name: | ULTRACELL SUCTION SPONGE |
| Classification | Catheter, Irrigation |
| Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK North Stonington, CT 06359 |
| Contact | George O Korteweg |
| Correspondent | George O Korteweg ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK North Stonington, CT 06359 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-10-01 |