The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Surge-free Aspiration Adapter.
Device ID | K020734 |
510k Number | K020734 |
Device Name: | SURGE-FREE ASPIRATION ADAPTER |
Classification | Unit, Phacofragmentation |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Contact | Herb Crane |
Correspondent | Herb Crane STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-06 |
Decision Date | 2002-05-16 |
Summary: | summary |