The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for U.s. Endoscopy Group, Inc. Balloon Replacement Gastrostomy Tube.
| Device ID | K955181 |
| 510k Number | K955181 |
| Device Name: | U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| 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 | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-06-05 |
| Summary: | summary |