The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Precisionedge-acc, Precisionedge-acs, Precisionedge-lsk, And Precisionedge-cb Microkeatome Blades.
| Device ID | K002849 |
| 510k Number | K002849 |
| Device Name: | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES |
| Classification | Keratome, Ac-powered |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Vikki M Hoffman |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-10-18 |