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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K942601
Device Name PSI FLEXIBLE ARM
Applicant
V. MUELLER NEURO/SPINE
871 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Applicant Contact TERRY JOHNSTON
Correspondent
V. MUELLER NEURO/SPINE
871 INDUSTRIAL RD.
SAN CARLOS,  CA  94070
Correspondent Contact TERRY JOHNSTON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/01/1994
Decision Date 12/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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