The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Pro-guard Double-duty Sterilization Wrap (single Use).
| Device ID | K962605 |
| 510k Number | K962605 |
| Device Name: | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) |
| Classification | Wrap, Sterilization |
| Applicant | SURGICOT, INC. 4018 PATRIOT DR., PO BOX 13956 Research Triangle Park, NC 27709 |
| Contact | Ben B Brock |
| Correspondent | Ben B Brock SURGICOT, INC. 4018 PATRIOT DR., PO BOX 13956 Research Triangle Park, NC 27709 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1997-03-11 |
| Summary: | summary |