The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Mehta Bronchial Biospy Drill.
| Device ID | K954693 |
| 510k Number | K954693 |
| Device Name: | MEHTA BRONCHIAL BIOSPY DRILL |
| Classification | Instrument, Biopsy, Suction |
| 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 | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-11 |
| Decision Date | 1995-10-23 |