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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bed, pediatric open hospital
510(k) Number K960012
Device Name STRYKER ADEL BASSINET
Applicant
STRYKER CORP.
MEDICAL DIV.
6300 SPRINKLE RD.
KALAMAZOO,  MI  49001 -6197
Applicant Contact CHAD COBERLY
Correspondent
STRYKER CORP.
MEDICAL DIV.
6300 SPRINKLE RD.
KALAMAZOO,  MI  49001 -6197
Correspondent Contact CHAD COBERLY
Regulation Number880.5140
Classification Product Code
FMS  
Date Received01/02/1996
Decision Date 03/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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