The following data is part of a premarket notification filed by J. Jamner Surgical Instruments, Inc. with the FDA for Jarit Endoscopes, Models 600-600; 600-630; 600-650; And 600-680.
| Device ID | K944870 |
| 510k Number | K944870 |
| Device Name: | JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | J. JAMNER SURGICAL INSTRUMENTS, INC. 9 SKYLINE DR. Hawthorne, NY 10532 |
| Contact | Patrice E Downey |
| Correspondent | Patrice E Downey J. JAMNER SURGICAL INSTRUMENTS, INC. 9 SKYLINE DR. Hawthorne, NY 10532 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1994-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2746307001 | K944870 | 000 |
| M2746307301 | K944870 | 000 |