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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 4 of 4 Results
ProductCode: DTE Applicant: OSYPKA MEDICAL, INC. Decision Date To: 03/24/2023
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psa series OSYPKA MEDICAL, INC. K123916 04/09/2013
pace 101/pace 101h, model 3077 ssi temporary pulse generator OSYPKA MEDICAL, INC. K033130 10/31/2003
oscor pace 101/101h and accessories, st.jude medical model 3077 and accessories,cardiotronic pace 101 and accessories OSYPKA MEDICAL, INC. K022939 10/03/2002
oscor pace 203/pace 203h dual-chamber temporary pacemaker, st. jude medical, model 3085 dual-chamber external pulse gene OSYPKA MEDICAL, INC. K020896 06/14/2002