The following data is part of a premarket notification filed by J. Jamner Surgical Instruments, Inc. with the FDA for Jarit Surgical Instruments.
Device ID | K931959 |
510k Number | K931959 |
Device Name: | JARIT SURGICAL INSTRUMENTS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | J. JAMNER SURGICAL INSTRUMENTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Contact | Beneke Jr. |
Correspondent | Beneke Jr. J. JAMNER SURGICAL INSTRUMENTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-21 |
Decision Date | 1993-10-05 |