The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Visual Endoscopic Non-alcohol Ultracell Sponge (venus).
| Device ID | K973558 |
| 510k Number | K973558 |
| Device Name: | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) |
| Classification | Accessories, Cleaning, For Endoscope |
| 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 | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-11-24 |
| Summary: | summary |