The following data is part of a premarket notification filed by Medical Action Industries, Inc. with the FDA for Surgicla Instrument Kit.
Device ID | K946019 |
510k Number | K946019 |
Device Name: | SURGICLA INSTRUMENT KIT |
Classification | Wrap, Sterilization |
Applicant | MEDICAL ACTION INDUSTRIES, INC. 537 SWEETEN CK. INDUSTRIAL PK. Asheville, NC 28803 |
Contact | Steve Woody |
Correspondent | Steve Woody MEDICAL ACTION INDUSTRIES, INC. 537 SWEETEN CK. INDUSTRIAL PK. Asheville, NC 28803 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-12 |
Decision Date | 1995-03-20 |