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510(k) K946003

INTEC FULL FACE SHIELD by Intec Industries, Inc. — Product Code LYU

K946003 is an FDA 510(k) premarket notification submitted by Intec Industries, Inc. for the device "INTEC FULL FACE SHIELD". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code LYU (Accessory, Surgical Apparel), a Class I device regulated under 21 CFR 878.4040. Intec Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
December 9, 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 Intec Industries, Inc.

  • K946343 — INTEC EXTENDED EYE SHIELD WITH MASK (March 22, 1995)

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