The following data is part of a premarket notification filed by Visitec Co. with the FDA for Aqueous Paracentesis Pipet.
| Device ID | K915808 |
| 510k Number | K915808 |
| Device Name: | AQUEOUS PARACENTESIS PIPET |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | David A Clapp |
| Correspondent | David A Clapp VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-03-19 |