The following data is part of a premarket notification filed by Beecher Medical Diagnostic Instrumentation with the FDA for Hepatic Parenchymal Suction Dissector.
Device ID | K850288 |
510k Number | K850288 |
Device Name: | HEPATIC PARENCHYMAL SUCTION DISSECTOR |
Classification | Dissector, Surgical, General & Plastic Surgery |
Applicant | BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION 9007 WOODLAND DR. Silver Spring, MD 20910 |
Contact | Stephen B Leighton |
Correspondent | Stephen B Leighton BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION 9007 WOODLAND DR. Silver Spring, MD 20910 |
Product Code | GDI |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-24 |
Decision Date | 1985-03-18 |