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510(k) K801819

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

K801819 is an FDA 510(k) premarket notification submitted by Robert I. Chien & Assoc., Inc. for the device "SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code HXD (Clamp), a Class I device regulated under 21 CFR 878.4800. Robert I. Chien & Assoc., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 31, 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)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

Other clearances for product code HXD

  • K890368 — KIDNEY CLAMP (February 3, 1989)
  • K890372 — INTESTINAL CLAMP (February 3, 1989)
  • K890381 — PARAMETRIUM CLAMP (February 3, 1989)
  • K890371 — INTESTINAL CRUSHING 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)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

FDA data resources