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510(k) K800444

GOLDEN RETRIEVERS OR SILVER RETRIEVERS by Instrument Makar, Inc. — Product Code HXB

K800444 is an FDA 510(k) premarket notification submitted by Instrument Makar, Inc. for the device "GOLDEN RETRIEVERS OR SILVER RETRIEVERS". The FDA issued a decision of Substantially Equivalent on March 5, 1980. The device falls under product code HXB (Probe), a Class I device regulated under 21 CFR 888.4540. Instrument Makar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1980
Date Received
February 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Instrument Makar, Inc.

  • K002600 — LITWIN CRUICATE ANCHOR (November 15, 2000)
  • K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT (November 6, 1998)
  • K963396 — BIOSPHERE SUTURE ANCHOR (May 6, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 1994)

Other clearances for product code HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K890227 — SURGICAL PROBE (January 27, 1989)
  • K873651 — BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 (November 2, 1987)
  • K873652 — HOOK PROBE #TM-1376 (November 2, 1987)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K841971 — 2.5MM & 4MM PROBE K841969-LABELING (June 19, 1984)
  • K840558 — SHUTT PRECISION PROBES (April 25, 1984)
  • K810294 — LINE CADDY (February 26, 1981)

FDA data resources