The following data is part of a premarket notification filed by Solway, Inc. with the FDA for Forceps Cliprack Ventricular Cannula Saws Spatulas.
Device ID | K874962 |
510k Number | K874962 |
Device Name: | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS |
Classification | Instrument, Surgical, Non-powered |
Applicant | SOLWAY, INC. POST OFFICE BOX 7647 Hollywood, FL 33081 |
Contact | Martin Munzer |
Correspondent | Martin Munzer SOLWAY, INC. POST OFFICE BOX 7647 Hollywood, FL 33081 |
Product Code | HAO |
CFR Regulation Number | 882.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-02 |
Decision Date | 1988-02-02 |