The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Jarit Surgical Instruments.
Device ID | K932072 |
510k Number | K932072 |
Device Name: | JARIT SURGICAL INSTRUMENTS |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Contact | Beneke Jr. |
Correspondent | Beneke Jr. MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-28 |
Decision Date | 1994-01-11 |