The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Knot Pusher.
Device ID | K924592 |
510k Number | K924592 |
Device Name: | DAVOL KNOT PUSHER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Contact | Mary M Mcnamara |
Correspondent | Mary M Mcnamara DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-10 |
Decision Date | 1992-12-17 |