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510(k) K920298

DISPOSABLE HEMOSTATS by Falcon Instruments, Inc. — Product Code HRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1992
Date Received
January 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostat
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Falcon Instruments, Inc.

  • K930775 — DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC (April 23, 1993)
  • K920297 — DISPOSABLE SCISSORS (September 11, 1992)
  • K920296 — DISPOSABLE FORCEPS (September 11, 1992)

Other clearances for product code HRQ

  • K895683 — BERNARD VESSEL APPROXIMATOR (October 24, 1989)
  • K890245 — SURGICAL HEMOSTATS (January 27, 1989)
  • K884196 — SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) (November 8, 1988)
  • K881937 — SURGICAL INSTRUMENTS (June 15, 1988)
  • K861807 — MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) (May 23, 1986)
  • K844152 — HEMSTATS (November 7, 1984)
  • K843593 — SURGIPRESS SURGICAL LOOP (October 24, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)
  • K834175 — OP-CON SURG. INSTRUMENTS #11 (January 27, 1984)
  • K831797 — HEMOSTATS (July 19, 1983)