The following data is part of a premarket notification filed by J. Jamner Surgical Instruments, Inc. with the FDA for Jarit Endoscopes, 600-600; 600-630; 600-650; 680.
Device ID | K931878 |
510k Number | K931878 |
Device Name: | JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | J. JAMNER SURGICAL INSTRUMENTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Contact | Kotula Cook |
Correspondent | Kotula Cook J. JAMNER SURGICAL INSTRUMENTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-14 |
Decision Date | 1993-08-19 |