The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Percutaneous Transhepatic Cholangiogram.
| Device ID | K854297 |
| 510k Number | K854297 |
| Device Name: | MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM |
| Classification | Instrument, Biopsy |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Donna Collier |
| Correspondent | Donna Collier MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-25 |
| Decision Date | 1985-11-26 |