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510(k) K915415

GUARDALL SHIELD by Anago, Inc. — Product Code LYU

K915415 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "GUARDALL SHIELD". The FDA issued a decision of Substantially Equivalent on October 15, 1992. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Anago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1992
Date Received
November 29, 1991
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 Anago, Inc.

  • K925659 — U.C.E.Z. LENS CLEANER KIT (September 17, 1993)
  • K930161 — ANAGO SPINAL ANESTHESIA TRAY (July 6, 1993)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (May 26, 1993)
  • K920615 — ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT (March 20, 1993)
  • K913558 — RELIABLE CONE STYLE FACE MASK (November 7, 1991)
  • K905865 — ANTI-FOR SURGICAL FACE MASK (March 6, 1991)
  • K905749 — SURGICAL FACE MASK (March 4, 1991)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)

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