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510(k) K820659

A CALIPER by Twin City Surgical, Inc. — Product Code KTZ

K820659 is an FDA 510(k) premarket notification submitted by Twin City Surgical, Inc. for the device "A CALIPER". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code KTZ (Caliper), a Class I device regulated under 21 CFR 888.4150. Twin City Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1982
Date Received
March 10, 1982
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

Other clearances by Twin City Surgical, Inc.

  • K870767 — THE (CROM) TESTER (March 17, 1987)
  • K861632 — SIMS CHAIR (May 27, 1986)
  • K830585 — ANVIL RETRACTOR (May 27, 1983)
  • K820660 — A HOOK DRIVER (March 19, 1982)
  • K813067 — SPINAL WRENCH (November 24, 1981)

Other clearances for product code KTZ

  • K921266 — NK MEDICAL MICROMETER, MODEL MC001 (July 14, 1992)
  • K841687 — SKYNDEX ELECTRONIC BODY FAT CALCULA (June 28, 1984)
  • K831898 — SCOLIMETER (July 19, 1983)
  • K810116 — ISOROBIC SKINFOLD CALIPER (February 4, 1981)
  • K800363 — PARKE-DAVIS TOTAL KNEE PROSTHESIS (March 10, 1980)
  • K760521 — TAPE MEASURE (November 12, 1976)

FDA data resources