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510(k) K880740

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE by Spectramed, Inc. — Product Code DQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1988
Date Received
February 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Actuator, Syringe, Injector Type
Device Class
Class II
Regulation Number
870.1670
Review Panel
HO
Submission Type

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  • K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (February 1, 1989)
  • K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (January 25, 1989)
  • K881825 — MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH (September 28, 1988)
  • K875337 — HEPARIN COATED LUMINAL PACING CATHETER (May 25, 1988)
  • K873168 — SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS (January 12, 1988)
  • K871573 — CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS (September 16, 1987)

Other clearances for product code DQF

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