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510(k) K943263

NIL by Sing Wah International Enterprises , Ltd. — Product Code HQY

K943263 is an FDA 510(k) premarket notification submitted by Sing Wah International Enterprises , Ltd. for the device "NIL". The FDA issued a decision of Substantially Equivalent on August 15, 1994. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Sing Wah International Enterprises , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1994
Date Received
July 7, 1994
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 Sing Wah International Enterprises , Ltd.

  • K943613 — NIL (September 21, 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)
  • K973528 — SUNGLASSES (December 8, 1997)
  • K974414 — MULTI (December 8, 1997)
  • K974179 — NON-PRESCRIPTION SUNGLASSES (December 1, 1997)
  • K974045 — VENNETO (November 20, 1997)
  • K973934 — SUNGLASSES (November 18, 1997)

FDA data resources