NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100

Unit, Phacofragmentation

UNITED SURGICAL CORP.

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.

Pre-market Notification Details

Device IDK870806
510k NumberK870806
Device Name:NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
ClassificationUnit, Phacofragmentation
Applicant UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine,  CA  92718
ContactTerry F Herbeck
CorrespondentTerry F Herbeck
UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine,  CA  92718
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-26
Decision Date1987-03-26

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