The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Jj Skinner Carekits Minor Surgical Procedure Tray.
Device ID | K961683 |
510k Number | K961683 |
Device Name: | JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY |
Classification | General Surgery Tray |
Applicant | J.J. SKINNER, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
Contact | Carlann Kotula |
Correspondent | Carlann Kotula J.J. SKINNER, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-01 |
Decision Date | 1996-05-10 |
Summary: | summary |