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510(k) K974179

NON-PRESCRIPTION SUNGLASSES by Taipan Optical Company , Ltd. — Product Code HQY

K974179 is an FDA 510(k) premarket notification submitted by Taipan Optical Company , Ltd. for the device "NON-PRESCRIPTION SUNGLASSES". The FDA issued a decision of Substantially Equivalent on December 1, 1997. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1997
Date Received
November 6, 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 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)
  • K974045 — VENNETO (November 20, 1997)
  • K973934 — SUNGLASSES (November 18, 1997)
  • K973526 — SUNGLASSES (October 16, 1997)

FDA data resources