The following data is part of a premarket notification filed by Perimetrics, Inc. with the FDA for Perimetrics Periometer.
Device ID | K072213 |
510k Number | K072213 |
Device Name: | PERIMETRICS PERIOMETER |
Classification | Handpiece, Direct Drive, Ac-powered |
Applicant | PERIMETRICS, INC. 27001 LA PAZ, SUITE 314 Mission Viejo, CA 92691 |
Contact | Albert Rego |
Correspondent | Albert Rego PERIMETRICS, INC. 27001 LA PAZ, SUITE 314 Mission Viejo, CA 92691 |
Product Code | EKX |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-09 |
Decision Date | 2008-08-29 |