The following data is part of a premarket notification filed by American Surgical Instruments Corp. with the FDA for Irrigation Pumps And Tubing And Suction Tubing.
| Device ID | K921457 |
| 510k Number | K921457 |
| Device Name: | IRRIGATION PUMPS AND TUBING AND SUCTION TUBING |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AMERICAN SURGICAL INSTRUMENTS CORP. 430 COMMERCE DRIVE, SUITE 50E Delray Beach, FL 33445 |
| Contact | Dorsey Iii |
| Correspondent | Dorsey Iii AMERICAN SURGICAL INSTRUMENTS CORP. 430 COMMERCE DRIVE, SUITE 50E Delray Beach, FL 33445 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-26 |
| Decision Date | 1993-05-13 |