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510(k) K942987

NUCLEOTOME L KIT by Surgical Dynamics, Inc. — Product Code GET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1995
Date Received
June 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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  • K913145 — NUCLEOTOME TISSUE ASPIRATOR/CUTTER (December 19, 1991)
  • K902778 — SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER (October 30, 1990)
  • K894336 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM (August 4, 1989)

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  • K914753 — AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (June 11, 1992)
  • K910071 — PORTA GAS COMPRESSED GAS CYLINDER CART (March 22, 1991)
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