The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Piezo Handpiece.
Device ID | K902150 |
510k Number | K902150 |
Device Name: | PIEZO HANDPIECE |
Classification | Unit, Phacofragmentation |
Applicant | UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
Contact | Dan Brostoff |
Correspondent | Dan Brostoff UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-15 |
Decision Date | 1990-07-05 |