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510(k) K844152

HEMSTATS by I M, Inc. — Product Code HRQ

K844152 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "HEMSTATS". The FDA issued a decision of Substantially Equivalent on November 7, 1984. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. I M, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

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)

FDA data resources