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510(k) K950058

Device
MC HEALTHCARE #CH31 CHILD'S CRIB
Applicant
JANCO CONSULTING SERVICES
510(k) number
K950058
Product code
FMS  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-10
Date received
1995-01-06
Regulation
880.5140
Classification name
Bed, Pediatric Open Hospital
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JANET SHAW
Address
6839 Montevideo Rd. Mississauga, Ontario L5n 1n7 CA L5N 1N7 L5N 1N7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FMS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970334NATURE'S CRADLEInfant Advantage, Inc.1997-04-25
K963210VAIL 100 PEDIATRIC CRIBVail Products, Inc.1996-11-13
K960747NATURE'S CRADLE MODEL C1500Infant Advantage, Inc.1996-05-22
K960012STRYKER ADEL BASSINETStryker Corp.1996-03-25
K951024NATURE'S CRADLEInfant Advantage, Inc.1995-06-05
K950059MC INFANT CARE UNIE #PP30Janco Consulting Services1995-02-10
K950051BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, BThe Brewer Co.1995-02-10
K925530INSTRUMENT WARMERSuperior Healthcare Group, Inc.1993-06-18
K925949PEDICRAGT BASSINETPedicraft, Inc.1993-04-20
K925817HEAD & FOOT END DROP PEDI-CRIBPedicraft, Inc.1993-04-20
K921327NATURE'S CRADLE HM-10Infant Advantage, Inc.1992-12-29
K901763NATURE'S CRADLE(TM)Infant Advantage, Inc.1991-03-22
K900873PEDIATRIC HOSPITAL BEDHospital Supply Co., Inc.1990-05-18
K883818MODIFIED REFLUX REDUCERPhysician Engineered Products, Inc.1988-11-21
K881019BABYROCKERCinventa AB1988-06-07

Legacy Summary#

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FDA Review#

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