The following data is part of a premarket notification filed by J. Jamner Surgical Instruments, Inc. with the FDA for Jarit Surgical Instruments: Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339.
| Device ID | K933728 |
| 510k Number | K933728 |
| Device Name: | JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | J. JAMNER SURGICAL INSTRUMENTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook 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 | 1993-08-02 |
| Decision Date | 1994-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M274615EC3301 | K933728 | 000 |
| M2746153381 | K933728 | 000 |
| M2746153351 | K933728 | 000 |
| M2746153311 | K933728 | 000 |
| M2746153301 | K933728 | 000 |
| M2746153391 | K933728 | 000 |
| M274615334HC1 | K933728 | 000 |
| M2746153341 | K933728 | 000 |