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510(k) K935165

BIKER MICE SUNGLASSES by Ja-Ru, Inc. — Product Code HQY

K935165 is an FDA 510(k) premarket notification submitted by Ja-Ru, Inc. for the device "BIKER MICE SUNGLASSES". The FDA issued a decision of Substantially Equivalent on January 6, 1994. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Ja-Ru, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1994
Date Received
October 29, 1993
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 Ja-Ru, Inc.

  • K941682 — COOL KIDS BEADS AND SHADES (May 17, 1994)
  • K935919 — SUNGLASSES (February 16, 1994)
  • K934402 — COOL KIDS MIRROR SHADES (January 25, 1994)
  • K934852 — COOL KIDS HIP SHADES (December 8, 1993)
  • K931389 — ITEM # 754 HOT FLIP SHADES (October 6, 1993)

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