FDA.reportPublic FDA data

510(k) K853855

Device
Xtal X-150 Operating Microscope
Applicant
XTAL CORP.
510(k) number
K853855
Product code
HRM
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-15
Date received
1985-09-16
Regulation
878.4700
Classification name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALAN P SCHWARTZ
Address
215 S. Hwy. 101 Suite 200-A Solana Beach CA US 92075 92075

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932720HM-0970Hill-Med, Inc.1993-09-07
K930439MARCO SURGISCOPE OPERATION MICROSCOPESMarco Ophthalmic, Inc.1993-07-22
K920641ALCON OPERATING MICROSCOPESAlcon Laboratories1992-10-09
K914956KEELER KONAN SPECULAR MICROSCOPE SP5500Keeler Instruments, Inc.1992-02-03
K891584S 22 INSTRUMENT STANDCarl Zeiss, Inc.1989-06-08
K891001MICROSCOPE KNOB COVER, STERILE, DISPOSABLEPrescott'S, Inc.1989-04-11
K854440MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50Keeler Instruments, Inc.1985-12-16
K852586CROMIC SURGICAL MICROSCOPE MODEL MC-1Seltrex, Corp.1985-07-30
K852150CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500Keeler Instruments, Inc.1985-06-03
K850270CORNEAL LIGHT SHIELDMentor O & O, Inc.1985-05-31
K844323KONAN CLINIC MICROSCOPE CLM-100-150Keeler Instruments, Inc.1984-11-21
K822563OPHTHALMIC MICROSCOPETreace Medical, Inc.1982-09-14
K792083HAAG-STREIT SLIT LAMP 900Lumenis, Inc.1979-11-16