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510(k) K102648

ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK by Shenzhen Ant Hi-Tech Industrial Co., Ltd. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2011
Date Received
September 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Shenzhen Ant Hi-Tech Industrial Co., Ltd.

  • K131770 — PRESSURE CONNECTING TUBE (February 26, 2014)
  • K091408 — DISPOSABLE PRESSURE TRANSDUCER (August 18, 2009)
  • K072696 — ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200 (May 2, 2008)

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  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
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  • K130566 — BASIXTOUCH (June 19, 2013)