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510(k) K810054

RICA (DIAGNOSTIC INSTRUMENTS) by Robert I. Chien & Assoc., Inc. — Product Code GWZ

K810054 is an FDA 510(k) premarket notification submitted by Robert I. Chien & Assoc., Inc. for the device "RICA (DIAGNOSTIC INSTRUMENTS)". The FDA issued a decision of Substantially Equivalent on January 28, 1981. The device falls under product code GWZ (Percussor), a Class I device regulated under 21 CFR 882.1700. Robert I. Chien & Assoc., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
January 12, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor
Device Class
Class I
Regulation Number
882.1700
Review Panel
NE
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)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

Other clearances for product code GWZ

  • K891571 — PERCUSSION HAMMER (March 31, 1989)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K851748 — 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE (June 13, 1985)
  • K834170 — OP-CON SURG. INSTRUMENT #10 (February 23, 1984)
  • K834178 — H.R. JAKOBI SURG. INSTR. #10 34/36 (February 23, 1984)
  • K840314 — CAT 10-NEUROLOGY DEVICE (February 23, 1984)
  • K803148 — CONPHAR PERCUSSION HAMMER(TAYLOR) (January 8, 1981)
  • K803174 — CONPHAR PERCUSSION HAMMER(BUCK TYPE) (December 30, 1980)
  • K791336 — BUCKS NEUROLOGICAL HAMMER (August 3, 1979)
  • K791337 — TAYLOR NEUROLOGICAL HAMMER (August 3, 1979)

FDA data resources