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510(k) K902558

COLLAGEN SHIELD FOR ACUTE CARE by Vitaphore Corp. — Product Code MOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1990
Date Received
June 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collagen Corneal Shield
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type

Other clearances by Vitaphore Corp.

  • K914579 — SILVER FOAM WOUND DRESSING (February 21, 1992)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K895920 — VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS (June 6, 1991)
  • K891993 — COLLAGEN NEUROSPONGE (March 23, 1990)
  • K896455 — VITACHOICE WOUND DRESSING (February 15, 1990)
  • K895993 — VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE (January 11, 1990)
  • K896046 — VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE (January 11, 1990)
  • K890435 — VITAACCESS CATHETER INTRODUCER KIT (March 29, 1989)
  • K882100 — VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT (July 13, 1988)
  • K872998 — VITAACCESS (TM) CATHETER INTRODUCER SYSTEM (March 24, 1988)

Other clearances for product code MOE

  • K944872 — BIO-COR COLLAGEN CORNEAL SHIELD (July 26, 1995)
  • K915861 — MEDILENS-CS CORNEAL SHIELD (March 6, 1992)
  • K914529 — SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (November 13, 1991)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K905825 — COLLAGEN SHIELD, VARIOUS MODELS (June 10, 1991)
  • K901880 — MEDILENS(TM) CORNEAL SHIELD (July 2, 1990)
  • K896449 — IM COLLAGEN SHIELD (May 24, 1990)
  • K884962 — ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (February 9, 1990)
  • K885015 — COI 72 HR COLLAGEN SHIELD (June 23, 1989)
  • K884960 — ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (February 13, 1989)