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510(k) K931042

MOORE SECURE CAP by Kerma Medical Products, Inc. — Product Code LYU

K931042 is an FDA 510(k) premarket notification submitted by Kerma Medical Products, Inc. for the device "MOORE SECURE CAP". The FDA issued a decision of Substantially Equivalent on April 13, 1994. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Kerma Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1994
Date Received
March 1, 1993
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 Kerma Medical Products, Inc.

  • K915821 — MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES (May 29, 1992)
  • K915822 — MULTIPLE DRESSING, STERILE NONADDHERENT PADS (March 26, 1992)
  • K914071 — MULTIPLE BURN DRESSING (December 4, 1991)
  • K914937 — STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES (December 4, 1991)

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)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)

FDA data resources