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510(k) K791162

GELSKIN by Spenco Medical Corp. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1979
Date Received
June 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

Other clearances by Spenco Medical Corp.

  • K981902 — SPENCO SILICONE GEL SHEET (June 25, 1998)
  • K922228 — 2ND SKIN STERILE ADHESIVE STRIP (December 11, 1992)
  • K911550 — 2ND SKIN MOIST BURN PADS WITH ALOE (September 6, 1991)
  • K910927 — SPENCIO SKIN GUARD KIT (June 3, 1991)
  • K896533 — SPENCO BREAST FORMS (December 13, 1989)
  • K894898 — 2ND SKIN NON-STICK MOIST BURN PADS (August 23, 1989)
  • K820906 — SPENCO CRYOPRESS (May 13, 1982)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K791726 — HYDROGEL-PREP (November 20, 1979)

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  • K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE (September 7, 2007)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K040317 — IVC SYSTEM (May 7, 2004)
  • K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (November 3, 1997)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)