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510(k) K931718

SPIRIT SHIELD by Eaton Medical Corp. — Product Code HQY

K931718 is an FDA 510(k) premarket notification submitted by Eaton Medical Corp. for the device "SPIRIT SHIELD". The FDA issued a decision of Substantially Equivalent on September 20, 1993. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Eaton Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1993
Date Received
April 6, 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 Eaton Medical Corp.

  • K921882 — THE CLEANER ACCESSORY (August 25, 1992)
  • K904824 — EASY EYES TM CONTACT LENS CLEANING MACHINE (July 5, 1991)
  • K871741 — EASY EYES TM LENS CARRYING CASE (July 22, 1987)
  • K841881 — EASY EYES TM LENS CARRYING CASE (December 3, 1984)

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