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510(k) K001217

Device
INSIDE VIEW
Applicant
MONADNOCK OPTICS, INC.
510(k) number
K001217
Product code
GCM  
Decision
Substantially Equivalent (SESE)
Decision date
2000-07-11
Date received
2000-04-17
Regulation
876.1500
Classification name
Endoscope, Rigid
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LEONARD J BONNELL
Address
1464 Holcomb Rd. Huntingdon Valley PA US 19006 19006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments Corporation2021-05-14
K083840MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPEMsi Medserv International Deutschland GmbH2009-09-28
K993103ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.1999-12-10
K993445OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical Technologies1999-12-06
K962393KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, Inc.1996-09-17
K950712PORTABLE ENDOSCOPY SYSTEMLaser-Optik-Systeme GmbH & Co. KG1996-05-14
K955120HAND-HELD RETRACTOR, DISSECTOR & DISSECTOREthicon Endo-Surgery, Inc.1996-01-26
K935235ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERYSmith & Nephew Richards, Inc.1995-03-23
K945889KARL STORZ PLASTIC SURGERY ACCESSORIESKARL STORZ Endoscopy-America, Inc.1995-03-22
K931954THORACOSCOPE/LAPAROSCOPESurgical Technologies, Inc.1993-11-02
K921918FIBER OPTIC ENDOSCOPEElectro Fiberoptics Corp.1993-08-17
K925918PRESSURE TURING AND ACCESSORIESApplied Medical Resources1993-02-12
K921883ENDOSCOPEOptimed Technologies, Inc.1992-11-23
K901464MEDILASE SERIES 2200 ENDOSCOPEMedical Laser, Inc.1990-08-07
K894592LAMANO DIRECTORSMarlo Surgical Technology1989-09-08

Legacy Summary#

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FDA Review#

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