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510(k) K900526

MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS by J & B Assoc. — Product Code HQY

K900526 is an FDA 510(k) premarket notification submitted by J & B Assoc. for the device "MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS". The FDA issued a decision of Substantially Equivalent on May 3, 1990. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. J & B Assoc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1990
Date Received
February 2, 1990
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 J & B Assoc.

  • K900528 — MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES (May 3, 1990)
  • K900527 — MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES (May 3, 1990)
  • K900520 — MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS (May 3, 1990)
  • K900521 — MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER (May 3, 1990)
  • K900524 — MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER (May 3, 1990)
  • K900522 — MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS (May 3, 1990)
  • K900529 — MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES (May 3, 1990)
  • K900525 — MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE (February 27, 1990)
  • K900523 — MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. (February 27, 1990)

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