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510(k) K920211

SUN/SPORTGLASSES by Bacou USA, Inc. and Uvex Safety, Inc. — Product Code HQY

K920211 is an FDA 510(k) premarket notification submitted by Bacou USA, Inc. and Uvex Safety, Inc. for the device "SUN/SPORTGLASSES". The FDA issued a decision of Substantially Equivalent on May 1, 1992. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Bacou USA, Inc. and Uvex Safety, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1992
Date Received
January 16, 1992
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 Bacou USA, Inc. and Uvex Safety, Inc.

  • K820016 — UVEX ALPHA, BETA, GAMMA & DELTA SUN (March 19, 1982)
  • K813548 — UVEX MINI-SPECS (March 2, 1982)

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