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 |