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510(k) K900764

SUNGLASS, NON-PRESCRIPTION by Seiko Optical Products of America, Inc. — Product Code HQY

K900764 is an FDA 510(k) premarket notification submitted by Seiko Optical Products of America, Inc. for the device "SUNGLASS, NON-PRESCRIPTION". The FDA issued a decision of Substantially Equivalent on June 20, 1990. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Seiko Optical Products of America, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
February 20, 1990
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 Seiko Optical Products of America, Inc.

  • K942513 — SEIKO EYEGLASS FRAME (July 15, 1994)
  • K873245 — AR DIACOAT SINGLE VISION LENSES (October 5, 1987)
  • K861684 — SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) (June 9, 1986)

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