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510(k) K844152

HEMSTATS by I M, Inc. — Product Code HRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1984
Date Received
October 24, 1984
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

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Other clearances for product code HRQ

  • K920298 — DISPOSABLE HEMOSTATS (August 11, 1992)
  • 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)
  • 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)