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510(k) K914529

SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS by Oasis Medical, Inc. — Product Code MOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
October 11, 1991
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

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  • K030401 — DISPOSABLE M2-PE MICROKERATOME BLADES (June 19, 2003)
  • K022205 — DISPOSABLE N-PE MICROKERATOME BLADES (October 3, 2002)
  • K013613 — SOFT PLUG ABSORBABLE PLUG-SA (June 27, 2002)
  • K003820 — DISPOSABLE CB-PE MICROKERATOME BLADES (March 8, 2001)
  • K001176 — DISPOSABLE MICROKERATOME BLADES-PE (September 21, 2000)
  • K980437 — SILICONE PUNCTAL PLUG (April 30, 1998)
  • K950798 — POSTERIOR CAPSULE SHIELD (May 22, 1995)

Other clearances for product code MOE

  • K944872 — BIO-COR COLLAGEN CORNEAL SHIELD (July 26, 1995)
  • K915861 — MEDILENS-CS CORNEAL SHIELD (March 6, 1992)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K905825 — COLLAGEN SHIELD, VARIOUS MODELS (June 10, 1991)
  • K902558 — COLLAGEN SHIELD FOR ACUTE CARE (August 17, 1990)
  • 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)
  • K884961 — ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (February 13, 1989)