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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K860593
Device Name ET/RT PAPILLOTOME
Applicant
Hobbs Medical, Inc.
P.O. Box 46
Spring St.
Stafford Springs,  CT  06076
Applicant Contact STEVEN G RICHTER
Correspondent
Hobbs Medical, Inc.
P.O. Box 46
Spring St.
Stafford Springs,  CT  06076
Correspondent Contact STEVEN G RICHTER
Regulation Number876.4300
Classification Product Code
KNS  
Date Received02/19/1986
Decision Date 07/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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