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 |