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510(k) K780759

MODEL 902 STAND by Applied Medical Research — Product Code FSH

K780759 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "MODEL 902 STAND". The FDA issued a decision of Substantially Equivalent on May 19, 1978. The device falls under product code FSH (Tray, Surgical, Needle), a Class I device regulated under 21 CFR 878.4800. Applied Medical Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1978
Date Received
May 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Needle
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Applied Medical Research

  • K800025 — DINAMAP RESEARCH MONITOR 1245 (February 1, 1980)
  • K791580 — CEREBRAL FUNCTION MONITOR 870 (September 4, 1979)
  • K791159 — DINAMAP MODEL 855 (July 30, 1979)
  • K790322 — OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 (May 14, 1979)
  • K790328 — MODEL 1051, MONITOR (March 2, 1979)
  • K782073 — DINAMAP MODELS 1160 AND 1165 (February 23, 1979)
  • K781053 — DINAMAP MODEL 846 (September 7, 1978)
  • K781064 — DINAMAP MODEL 848 (September 7, 1978)
  • K781311 — ELECTRODE, NEEDLE, CFM (August 21, 1978)
  • K780754 — NEONATAL MONITOR (June 14, 1978)

Other clearances for product code FSH

  • K884876 — S 4 INSTRUMENT STAND (December 15, 1988)
  • K883578 — S 21 INSTRUMENT STAND (September 13, 1988)
  • K821921 — STAND, SURG. INSTRUMENT & DRESSING (July 30, 1982)
  • K813338 — BIOPSY NEEDLES & TRAYS (January 28, 1982)
  • K813337 — SKINNY CHIBA NEEDLE & TRAY (January 28, 1982)
  • K813335 — PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY (January 8, 1982)
  • K772188 — FSH RIA KIT (125I) (December 22, 1977)

FDA data resources