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510(k) K946091

AVON SUNNY DAYS SUNGLASSES by Siegel,Mandell & Davidson,P.C. — Product Code HQY

K946091 is an FDA 510(k) premarket notification submitted by Siegel,Mandell & Davidson,P.C. for the device "AVON SUNNY DAYS SUNGLASSES". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Siegel,Mandell & Davidson,P.C. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
December 14, 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 Siegel,Mandell & Davidson,P.C.

  • K951008 — POWER RANGERS SUNGLASSES (May 2, 1995)
  • K950931 — AVON MASSAGING HAIRBRUSH (April 5, 1995)
  • K946092 — AVON SUNNY DAYS SUNGLASSES (January 31, 1995)
  • K941369 — AVON CAT SUNGLASSES (May 17, 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