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510(k) K870806

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 by United Surgical Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by United Surgical Corp.

  • K902150 — PIEZO HANDPIECE (July 5, 1990)
  • K870671 — PHACOTRON DAY PAK (April 6, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)
  • K860014 — SYSTEMS PLUS (March 5, 1986)
  • K830741 — PARAMETRIC STERILITY RELEASE OF AUTO (August 11, 1983)

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