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510(k) K803156

SURGITEK MEDI-LOOPS by Medical Engineering Corp. — Product Code KDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1981
Date Received
December 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K842748 — SURGITEK RECONSTRUC-NIPPLE PROSTHESIS (September 26, 1984)

Other clearances for product code KDC

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  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)