The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Surgical Clipper.
Device ID | K910524 |
510k Number | K910524 |
Device Name: | SURGICAL CLIPPER |
Classification | Razor, Surgical |
Applicant | BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
Contact | Stephen A Campbell |
Correspondent | Stephen A Campbell BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
Product Code | LWK |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-07 |
Decision Date | 1991-03-28 |