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510(k) K990912

MTP EXTRACTION BAG by Mtp Medical Technical Promotion GmbH — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1999
Date Received
March 18, 1999
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 Mtp Medical Technical Promotion GmbH

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K021811 — UNIDRIVE II PLUS DISPOSABLE TUBING SET (June 19, 2002)
  • K020599 — MTP CLEARVISION DISPOSABLE TUBING SET (March 13, 2002)
  • K011360 — MTP LAPAROMAT DISPOSABLE TUBING SET (July 19, 2001)
  • K000337 — MTP DISPOSABLE TROCAR VALVES (April 12, 2000)
  • K994066 — MTP DISPOSABLE TROCARS (January 20, 2000)
  • K990909 — MTP UROPUMP DISPOSABLE TUBING SET (June 9, 1999)
  • K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET (June 3, 1999)
  • K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS (June 3, 1999)

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