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510(k) K970895

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

K970895 is an FDA 510(k) premarket notification submitted by Custom Optical Frames, Inc. for the device "CUSTOM OPTICAL SUNGLASS FRAMES". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Custom Optical Frames, Inc. has at least 3 other 510(k) clearances on record.

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

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

FDA data resources