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510(k) K801312

THE PROTECTORS by Cooper Medical Devices Corp.

K801312 is an FDA 510(k) premarket notification submitted by Cooper Medical Devices Corp. for the device "THE PROTECTORS". The FDA issued a decision of Substantially Equivalent on June 17, 1980. Cooper Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
June 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Cooper Medical Devices Corp.

  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K801850 — CHARLES PNEUMATIC INTRAOCULAR SCISSORS (September 16, 1980)
  • K801411 — MAY ILLUMINATED/INFUSION PIC (July 21, 1980)
  • K800833 — VABRA ASPIRATOR (May 14, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

FDA data resources