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510(k) K961454

AMMI MAGNI-GUARD by American Medical Mfg., Inc. — Product Code LYU

K961454 is an FDA 510(k) premarket notification submitted by American Medical Mfg., Inc. for the device "AMMI MAGNI-GUARD". The FDA issued a decision of Substantially Equivalent on July 25, 1996. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. American Medical Mfg., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
April 15, 1996
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 American Medical Mfg., Inc.

  • K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL (April 6, 1999)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K915065 — I.V.IRRIGATION POLE (February 11, 1992)
  • K915068 — PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER (February 6, 1992)

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)
  • 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)
  • K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (August 7, 1995)

FDA data resources