The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Non-sterile, Extra Plus Pak Cat. #uspk 2100.
Device ID | K870806 |
510k Number | K870806 |
Device Name: | NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 |
Classification | Unit, Phacofragmentation |
Applicant | UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
Contact | Terry F Herbeck |
Correspondent | Terry F Herbeck 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 | 1987-02-26 |
Decision Date | 1987-03-26 |