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510(k) K896449

IM COLLAGEN SHIELD by Intermedical, Inc. — Product Code MOE

K896449 is an FDA 510(k) premarket notification submitted by Intermedical, Inc. for the device "IM COLLAGEN SHIELD". The FDA issued a decision of Substantially Equivalent on May 24, 1990. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1990
Date Received
November 9, 1989
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 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)
  • K902558 — COLLAGEN SHIELD FOR ACUTE CARE (August 17, 1990)
  • K901880 — MEDILENS(TM) CORNEAL SHIELD (July 2, 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)

FDA data resources