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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, vibration threshold measurement
510(k) Number K964815
Device Name AP-4000, AIR PULSE SENSORY STIMULATOR
Applicant
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Applicant Contact PAUL SILVA
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Correspondent Contact PAUL SILVA
Regulation Number882.1200
Classification Product Code
LLN  
Date Received11/29/1996
Decision Date 09/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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