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510(k) K803067

SURG-FLEX 10 LIGHT by Medical Products Development, Inc. — Product Code FSQ

K803067 is an FDA 510(k) premarket notification submitted by Medical Products Development, Inc. for the device "SURG-FLEX 10 LIGHT". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code FSQ (Light, Surgical, Instrument), a Class II device regulated under 21 CFR 878.4580. Medical Products Development, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1981
Date Received
December 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Instrument
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Medical Products Development, Inc.

  • K810013 — MULTIPERFECTEMP CAUTERY (April 23, 1981)
  • K810016 — REPLACABLE BATTERY PERFECTEMP CAUTERY (April 23, 1981)
  • K810012 — MULTIMICRO SURGICAL CAUTERY (April 23, 1981)
  • K810015 — MULTIHI-TEMP CAUTERY (February 12, 1981)
  • K810014 — REPLACABLE BATTERY HI-TEMP CAUTERY (February 12, 1981)
  • K802942 — HITEMP. TM 2 LOOPTIP CAUTERY (February 4, 1981)
  • K810019 — SURG-FLEX 15 SURGICAL LIGHT (January 23, 1981)
  • K810018 — SURG-FLEX 5 SURGICAL LIGHT (January 23, 1981)
  • K810017 — MICROSURG CAUTERY (January 5, 1981)
  • K802330 — HI-TEMP LOOPTIP SURGICAL CAUTERY (November 12, 1980)

Other clearances for product code FSQ

  • K932139 — LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT (July 30, 1993)
  • K930686 — MIDMARK SURGICAL LIGHTING SYSTEMS (July 30, 1993)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K921848 — BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (October 1, 1992)
  • K810019 — SURG-FLEX 15 SURGICAL LIGHT (January 23, 1981)
  • K810018 — SURG-FLEX 5 SURGICAL LIGHT (January 23, 1981)

FDA data resources