PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES


information about

Device Classification Name

keratome, ac-powered

510(k) Number K002849
Device Name PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
Original Applicant
SURGICAL SPECIALTIES CORP.
100 dennis dr.
reading, 
PA 
19606

Original Contact vikki m hoffman
Regulation Number 886.4370
Classification Product Code
HNO  
Date Received 09/13/2000
Decision Date 10/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party Yes

Combination Product

No