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510(k) K942022

FACE-IT SHIELD by Onyx Medical Corp. — Product Code LYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1994
Date Received
April 26, 1994
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 Onyx Medical Corp.

  • K041679 — COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT (December 16, 2004)
  • K931690 — SPOON PLATE (June 7, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931692 — T-PLATE (May 4, 1994)
  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K931687 — MULTIPLE FRAGMENT PLATE (April 25, 1994)
  • K931685 — FOREARM SELF COMPRESSION PLATE (April 25, 1994)
  • K931691 — STRAIGHT MINI-PLATE (April 25, 1994)
  • K931693 — 1/3 TUBULAR PLATE (April 25, 1994)

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)