The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Electrosugical Probes.
Device ID | K915406 |
510k Number | K915406 |
Device Name: | DAVOL ELECTROSUGICAL PROBES |
Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Contact | Robin Dargo |
Correspondent | Robin Dargo DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
Product Code | HFG |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-02 |
Decision Date | 1992-02-28 |