The following data is part of a premarket notification filed by Conway Stuart Medical, Inc. with the FDA for Conway Stuart Model 100 Irrigation Pump & Accessories.
Device ID | K990724 |
510k Number | K990724 |
Device Name: | CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CONWAY STUART MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
Contact | Thomas Wehman |
Correspondent | Thomas Wehman CONWAY STUART MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-05 |
Decision Date | 1999-08-13 |