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510(k) K800363

PARKE-DAVIS TOTAL KNEE PROSTHESIS by Warner-Lambert Co. — Product Code KTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1980
Date Received
February 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caliper
Device Class
Class I
Regulation Number
888.4150
Review Panel
OR
Submission Type

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  • K850409 — GEN. DIAG. CHROMOSTRATE REF. PLASMA (May 8, 1985)
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Other clearances for product code KTZ

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  • K841687 — SKYNDEX ELECTRONIC BODY FAT CALCULA (June 28, 1984)
  • K831898 — SCOLIMETER (July 19, 1983)
  • K820659 — A CALIPER (March 19, 1982)
  • K810116 — ISOROBIC SKINFOLD CALIPER (February 4, 1981)
  • K760521 — TAPE MEASURE (November 12, 1976)