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510(k) K801028

RICA OR SMIC SURGICAL INSTRUMENTS by Robert I. Chien & Assoc., Inc. — Product Code HXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
May 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Robert I. Chien & Assoc., Inc.

  • K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (August 19, 1982)
  • K811632 — UNSTERILIZED LAPAROTOMY SPONGES (CHINA) (September 11, 1981)
  • K811631 — THERMOMETER (MADE IN CHINA) (July 20, 1981)
  • K810054 — RICA (DIAGNOSTIC INSTRUMENTS) (January 28, 1981)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)

Other clearances for product code HXD

  • K890371 — INTESTINAL CRUSHING CLAMP (February 3, 1989)
  • K890368 — KIDNEY CLAMP (February 3, 1989)
  • K890372 — INTESTINAL CLAMP (February 3, 1989)
  • K890381 — PARAMETRIUM CLAMP (February 3, 1989)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K872386 — C CLAMP (July 2, 1987)
  • K863653 — SUCTION-OFF (October 7, 1986)
  • K853538 — CANNULA CLAMP (September 12, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)