The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Endogator Endoscopy Irrigation Pump, Model Egp-100.
| Device ID | K060962 |
| 510k Number | K060962 |
| Device Name: | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | BYRNE MEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333243037 | K060962 | 000 |
| 30677964085605 | K060962 | 000 |
| 00677964085611 | K060962 | 000 |
| 04961333240791 | K060962 | 000 |
| 04961333240807 | K060962 | 000 |
| 04961333240814 | K060962 | 000 |
| 04961333240821 | K060962 | 000 |
| 04961333241699 | K060962 | 000 |
| 04961333241705 | K060962 | 000 |
| 04961333241712 | K060962 | 000 |
| 04961333241736 | K060962 | 000 |
| 04961333241743 | K060962 | 000 |
| 04961333241873 | K060962 | 000 |
| 04961333241880 | K060962 | 000 |
| 04961333243006 | K060962 | 000 |
| 04961333243013 | K060962 | 000 |
| 04961333243020 | K060962 | 000 |
| 30677964085599 | K060962 | 000 |