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510(k) K884380

Device
BED SHEET, PILLOW CASE
Applicant
SAYBREX INTL., INC.
510(k) number
K884380
Product code
KME  
Decision
Substantially Equivalent (SESE)
Decision date
1988-11-08
Date received
1988-10-18
Regulation
880.6060
Classification name
Bedding, Disposable, Medical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH BUSSEL
Address
215 1/2 S. Arnaz Dr. Beverly Hills CA US 90211 90211

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042145READY-HEAT BLANKETTechtrade, LLC2004-09-17
K944953OREX MEDICAL BEDDINGThantex Specialties, Inc.1994-12-02
K933636DISPOSE-A-SHEETBelmac Healthcare Corp.1994-01-26
K932539DOCTOR DOWN --RESCUE WRAPThree Dog Down1993-11-02
K922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.1992-08-10
K915303FOIL BABY BUNTINGGam Industries, Inc.1992-02-20
K912257CHEM-SLEEVE BHaz-Med, Inc.1991-12-31
K911948MEDI GUARD PILLOWCASESancella, Inc.1991-05-28
K911952MEDI GUARD UNDERPADSancella, Inc.1991-05-28
K911953MEDI GUARD SHEETS/UNDERLAYSSancella, Inc.1991-05-28
K911950MEDI GUARD DRAPESSancella, Inc.1991-05-21
K905003BIO-GUARD SHAVE PREP TRAYNetwork Medical Systems, Inc.1990-12-28
K904274RECEIVING BLANKETAnago, Inc.1990-10-26
K901509TRAUMA SLEEVEHaz-Med, Inc.1990-09-12
K901629CHEM-SLEEVEHaz-Med, Inc.1990-04-27

Legacy Summary#

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FDA Review#

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