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510(k) K092821

TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 by Agency For Medical Innovations, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2010
Date Received
September 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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).

Other clearances by Agency For Medical Innovations, Inc.

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  • K150718 — Wi-3 HAL-RAR System (June 12, 2015)

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