The following data is part of a premarket notification filed by Viatro, Corp. with the FDA for Virapump Ii (models And Model M).
| Device ID | K961607 |
| 510k Number | K961607 |
| Device Name: | VIRAPUMP II (MODELS AND MODEL M) |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | VIATRO, CORP. 6779 ENGLE RD. Cleveland, OH 44130 |
| Contact | Jan J Lewandowski |
| Correspondent | Jan J Lewandowski VIATRO, CORP. 6779 ENGLE RD. Cleveland, OH 44130 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-25 |
| Decision Date | 1996-12-06 |