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510(k) K952438

SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) by Taiwan Eva Industrial Co., Inc. — Product Code HQY

K952438 is an FDA 510(k) premarket notification submitted by Taiwan Eva Industrial Co., Inc. for the device "SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)". The FDA issued a decision of Substantially Equivalent on September 12, 1995. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Taiwan Eva Industrial Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1995
Date Received
May 25, 1995
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 Taiwan Eva Industrial Co., Inc.

  • K945350 — FRAME, SPECTACLES (December 13, 1994)
  • K945351 — SHIELD, EYE, OPHTHALMIC (December 13, 1994)

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