The following data is part of a premarket notification filed by Nashville Surgical Instruments with the FDA for Pre-view Cholangiography Clamp.
| Device ID | K973621 |
| 510k Number | K973621 |
| Device Name: | PRE-VIEW CHOLANGIOGRAPHY CLAMP |
| Classification | Catheter, Cholangiography |
| Applicant | NASHVILLE SURGICAL INSTRUMENTS 322 NORTHCREST DR. Springfield, TN 37172 |
| Contact | S.s. Kumar |
| Correspondent | S.s. Kumar NASHVILLE SURGICAL INSTRUMENTS 322 NORTHCREST DR. Springfield, TN 37172 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-23 |
| Decision Date | 1997-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B361KC2XL0 | K973621 | 000 |
| B361KC0020 | K973621 | 000 |
| B361CC0190 | K973621 | 000 |