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510(k) K953089

I-SPOUSE by Products For Medicine — Product Code LYU

K953089 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "I-SPOUSE". The FDA issued a decision of Substantially Equivalent on October 16, 1995. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Products For Medicine has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1995
Date Received
July 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Products For Medicine

  • K963227 — WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 (October 23, 1996)
  • K955510 — X6000D SILENT SUN LIGHT SOURCE (January 31, 1996)
  • K951704 — NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION (June 28, 1995)
  • K951703 — TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS (June 28, 1995)
  • K883658 — I-SPOSE EYE SHIELD (October 25, 1988)

Other clearances for product code LYU

  • K011755 — STRYKER T4 HYTREL (R) TOGAS (June 22, 2001)
  • K965237 — NURSES BOUFFANT CAP (August 27, 1997)
  • K970988 — FAR-EAST BOUFFANT CAPS (July 10, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K961791 — DEPUY DISPOSABLE FILTER/HOOD (August 9, 1996)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K945302 — SLOAN STA-DRI PANT PROTECTOR (March 19, 1996)
  • K954314 — ULTRAFIT LINERS (December 28, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)

FDA data resources