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510(k) K884362

LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD by Bausch & Lomb Pharmaceutical, Inc. — Product Code HQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1988
Date Received
October 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Absorbable, (Scleral Buckling Methods)
Device Class
Class II
Regulation Number
886.3300
Review Panel
OP
Submission Type

Other clearances by Bausch & Lomb Pharmaceutical, Inc.

  • K884962 — ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (February 9, 1990)
  • K884960 — ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (February 13, 1989)
  • K884961 — ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (February 13, 1989)
  • K884363 — LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL (November 29, 1988)
  • K884364 — LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL (November 29, 1988)

Other clearances for product code HQJ

  • K896350 — TITAN AIR SPECTACLE FRAME (December 18, 1989)
  • K875014 — LABTICIAN RETINAL IMPLANTS (February 26, 1988)
  • K831773 — MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK (August 16, 1983)
  • K760550 — IMPLANT, SILICONE AND TANTALUM (October 5, 1976)