The following data is part of a premarket notification filed by American Surgical Instruments Corp. with the FDA for Nezhat Dorsey Suction Probe W/inner Irriga Tube.
| Device ID | K913999 |
| 510k Number | K913999 |
| Device Name: | NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AMERICAN SURGICAL INSTRUMENTS CORP. 901 EAST SAMPLE ROAD, SUITE C Pompano Beach, FL 33064 |
| Contact | James H Dorsey |
| Correspondent | James H Dorsey AMERICAN SURGICAL INSTRUMENTS CORP. 901 EAST SAMPLE ROAD, SUITE C Pompano Beach, FL 33064 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1991-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741077098 | K913999 | 000 |
| 00801741077067 | K913999 | 000 |
| 00801741077036 | K913999 | 000 |