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510(k) K882413

SUBOCCIPITAL ICE PILLOW by Ferguson Medical — Product Code IME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1988
Date Received
June 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Reusable
Device Class
Class I
Regulation Number
890.5700
Review Panel
PM
Submission Type

Other clearances by Ferguson Medical

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  • K963794 — PUNCTURENEEDLE (March 19, 1998)
  • K962615 — TUMORLOCALIZER MRI (March 19, 1998)
  • K971813 — EMBLA (January 16, 1998)
  • K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
  • K972217 — ORTHOPEDIC SCREW SYSTEM (November 20, 1997)
  • K970819 — TARGOBEAM (July 14, 1997)
  • K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTE (May 22, 1997)
  • K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMOR (May 22, 1997)
  • K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)

Other clearances for product code IME

  • K923627 — COLD PACK (April 14, 1993)
  • K915876 — HOTPAD (February 12, 1993)
  • K921446 — HOT OR COLD PACK (THERMIPAQ) (July 13, 1992)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)
  • K863654 — RE-HEATER, HOT PACK (October 23, 1986)
  • K832193 — NICE PACK (August 31, 1983)
  • K831899 — ENSWELL (July 7, 1983)
  • K830981 — MICROPAK MOIST HEAT PAD (June 3, 1983)
  • K830416 — ICY COLD ICE CAP (March 10, 1983)
  • K823649 — THERMOELASTOMER HOT/COLD COMPRESS BK7186 (January 21, 1983)