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510(k) K003790

DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 by Davol, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2000
Date Received
December 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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  • K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (January 22, 2001)
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  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K935503 — DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET (March 7, 1994)
  • K926479 — BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM (March 1, 1994)

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