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510(k) K931389

ITEM # 754 HOT FLIP SHADES by Ja-Ru, Inc. — Product Code HQY

K931389 is an FDA 510(k) premarket notification submitted by Ja-Ru, Inc. for the device "ITEM # 754 HOT FLIP SHADES". The FDA issued a decision of Substantially Equivalent on October 6, 1993. 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
October 6, 1993
Date Received
March 18, 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)
  • K935165 — BIKER MICE SUNGLASSES (January 6, 1994)
  • K934852 — COOL KIDS HIP SHADES (December 8, 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