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510(k) K970895

CUSTOM OPTICAL SUNGLASS FRAMES by Custom Optical Frames, Inc. — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
March 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Device Class
Class I
Regulation Number
886.5850
Review Panel
OP
Submission Type

Other clearances by Custom Optical Frames, Inc.

  • K962478 — (BRAND NAME) SUNGLASS FRAMES (July 25, 1996)
  • K944373 — SPECTACLE FRAMES (September 28, 1994)
  • K925224 — U108, U105, G209-B (September 1, 1993)

Other clearances for product code HQY

  • K974852 — NON-PRESCRIPTION SUNGLASSES (January 30, 1998)
  • K974860 — NON-PRESCRIPTION SUNGLASSES (January 30, 1998)
  • K974861 — NON-PRESCRIPTION SUNGLASSES (January 27, 1998)
  • K974511 — SUNGLASSES (January 12, 1998)
  • K974441 — SUNGLASSES (January 9, 1998)
  • K973528 — SUNGLASSES (December 8, 1997)
  • K974414 — MULTI (December 8, 1997)
  • K974179 — NON-PRESCRIPTION SUNGLASSES (December 1, 1997)
  • K974045 — VENNETO (November 20, 1997)
  • K973934 — SUNGLASSES (November 18, 1997)