The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Bard Laparoscopic Irrigator Pump System.
Device ID | K902722 |
510k Number | K902722 |
Device Name: | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Contact | Annette M Fagnant |
Correspondent | Annette M Fagnant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-20 |
Decision Date | 1990-11-16 |