The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Endoboot.
| Device ID | K951104 |
| 510k Number | K951104 |
| Device Name: | ENDOBOOT |
| Classification | Endoscopic Storage Cover |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Gretchen Younker |
| Correspondent | Gretchen Younker UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | OCU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-10 |
| Decision Date | 1995-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20724995184029 | K951104 | 000 |
| 20724995184012 | K951104 | 000 |