The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Disposable Endoscopic Retrieval Device.
| Device ID | K962676 |
| 510k Number | K962676 |
| Device Name: | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE |
| Classification | Dislodger, Stone, Flexible |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Dean Secrest |
| Correspondent | Dean Secrest UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | FGO |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-09 |
| Decision Date | 1996-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995182783 | K962676 | 000 |
| 10724995182660 | K962676 | 000 |