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510(k) K860953

SUNGLASSES (NON-PRESCRIPTION) by Roseburg SA — Product Code HQY

K860953 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "SUNGLASSES (NON-PRESCRIPTION)". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Roseburg SA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
March 13, 1986
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 Roseburg SA

  • K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE (September 1, 1994)
  • K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES (March 9, 1989)
  • K885275 — ASSENAT-BLESCHET SUNGLASSES (January 24, 1989)
  • K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES (August 26, 1988)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR (November 17, 1987)
  • K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (July 21, 1987)
  • K871688 — SPECTACLE FRAME - DANIELLE (May 29, 1987)
  • K871689 — SPECTACLE FRAME - LORRAINE (May 29, 1987)
  • K870654 — EFER ARTHROSCOPE (May 14, 1987)

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