The following data is part of a premarket notification filed by Surgical Products Corp. with the FDA for Anterior Cruciate Ligament Grasper.
Device ID | K841241 |
510k Number | K841241 |
Device Name: | ANTERIOR CRUCIATE LIGAMENT GRASPER |
Classification | Arthroscope |
Applicant | SURGICAL PRODUCTS CORP. P.O. BOX 569 Salt Lake City , UT 84110 - |
Contact | Richard W Baggett |
Correspondent | Richard W Baggett SURGICAL PRODUCTS CORP. P.O. BOX 569 Salt Lake City , UT 84110 - |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-23 |
Decision Date | 1985-02-06 |