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510(k) K943562

SUNGLASSES by Australian Optical Co., Inc. — Product Code HQY

K943562 is an FDA 510(k) premarket notification submitted by Australian Optical Co., Inc. for the device "SUNGLASSES". The FDA issued a decision of Substantially Equivalent on September 14, 1994. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Australian Optical Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
July 22, 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 Australian Optical Co., Inc.

  • K943561 — SPECTACLE FRAME (September 14, 1994)
  • K943641 — SPECTACLE FRAME (September 14, 1994)
  • K943640 — SUNGLASS CLIP (September 14, 1994)
  • K935678 — SUNGLASS FRAME (February 16, 1994)
  • K930331 — SPECTACLE FRAME (December 8, 1993)
  • K911332 — SPECTACLE FRAME (May 6, 1991)
  • K910179 — OPTICAL FRAME (April 10, 1991)

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