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510(k) K946132

PROWAY by Union Industrial Co., Ltd. — Product Code HQY

K946132 is an FDA 510(k) premarket notification submitted by Union Industrial Co., Ltd. for the device "PROWAY". The FDA issued a decision of Substantially Equivalent on January 17, 1995. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Union Industrial Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1995
Date Received
December 16, 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 Union Industrial Co., Ltd.

  • K892791 — PATIENT EXAMINATION GLOVES (LATEX) (August 24, 1989)
  • K892919 — LATEX DISPOSABLE EXAMINATION GLOVES (June 7, 1989)

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