The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Surgiclean Enzymatic Instrument Cleaner.
| Device ID | K931270 |
| 510k Number | K931270 |
| Device Name: | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | SURGICOT, INC. ONE PARK CENTER PATRIOT DR.,PO BOX 13956 Research Triangle Park, NC 27709 |
| Contact | Glenn Mattei |
| Correspondent | Glenn Mattei SURGICOT, INC. ONE PARK CENTER PATRIOT DR.,PO BOX 13956 Research Triangle Park, NC 27709 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-08 |
| Decision Date | 1994-04-13 |