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510(k) K862315

FYODOROV COLLAGEN CORNEAL SHIELD by Medical Technology Development Corp. — Product Code MOE

K862315 is an FDA 510(k) premarket notification submitted by Medical Technology Development Corp. for the device "FYODOROV COLLAGEN CORNEAL SHIELD". The FDA issued a decision of Substantially Equivalent on January 7, 1987. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Medical Technology Development Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1987
Date Received
June 18, 1986
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 Medical Technology Development Corp.

  • K941488 — DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER (November 30, 1994)
  • K863727 — FIXATION INSTRUMENTS (October 31, 1986)
  • K863725 — CATARACT DIAMOND KNIFE (October 31, 1986)
  • K863726 — INSTRUMENT STERILIZATION TRAY (October 14, 1986)

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)
  • 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)

FDA data resources