The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Ultracell Absorbent Stick.
| Device ID | K012196 |
| 510k Number | K012196 |
| Device Name: | ULTRACELL ABSORBENT STICK |
| Classification | Sponge, Ophthalmic |
| Applicant | ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK North Stonington, CT 06359 |
| Contact | Colleen Martin |
| Correspondent | Colleen Martin ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK North Stonington, CT 06359 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-08-24 |