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510(k) Data Aggregation
K Number
K051610Device Name
HANS HERMANN LAPAROSCOPES AND ACCESSORIES
Manufacturer
HANS HERMANN GMBH
Date Cleared
2005-07-29
(42 days)
Product Code
GCJ, GEI
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
HANS HERMANN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laparosopes and accessories are intended for use in providing access to and visualization of organs, and canals to perform various diagnostic and therapeutic surgical procedures.
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.
Device Description
The Hans Hermann Laparoscopes and accessories consists of
- uls Hermann Daparoped surgical instruments with and without monopolar high frequency connection
- bipolar electrodes and accessories -
- monopolar electrodes and accessories -
- monopolar cicchrodos and accessories, Verres needles and suction-/irrigation systems,
- several Endoscopes (Laparoscope, Arthroscope, Cystoscope) -
- and a light cable -
The body contact portions of the Laparoscopes and accessories are composed of The body comace stainless steel, PTFE, PEEK, several coatings, silicon and brass surgical grade stamicss stock, in medical devices for a wide range of chiromutin placer which is commonly of biocompatibility for human use at short term contact.
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K Number
K983535Device Name
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010
Manufacturer
HANS HERMANN GMBH
Date Cleared
1998-12-29
(81 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
HANS HERMANN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hermann Titanium (Mini/Micro/Medium) plating systems are intended for maxillo-facial surgery.
The various sizes are designed to accommodate osteosynthesis requirements in pediatric and adult patients.
Medical Indications
Fractures in maxillo-facial bones -
Device Description
The Titanium Miniplating System H12-10104 - H19-30302
The Titanium Microplating System H22-01990 - H29-30302
The Titanium Mediumplating System H32-06104 - H39-30302
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