Home / 510(k) Clearances / K974861

510(k) K974861

NON-PRESCRIPTION SUNGLASSES by Wenzhou Hindar Optical Co., Ltd. — Product Code HQY

K974861 is an FDA 510(k) premarket notification submitted by Wenzhou Hindar Optical Co., Ltd. for the device "NON-PRESCRIPTION SUNGLASSES". The FDA issued a decision of Substantially Equivalent on January 27, 1998. 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
January 27, 1998
Date Received
December 29, 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)
  • 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)
  • K973526 — SUNGLASSES (October 16, 1997)

FDA data resources