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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K884057
Device Name ELAN-E DISPOSABLE DRAPE
Applicant
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Applicant Contact ROBIN BUSH
Correspondent
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Correspondent Contact ROBIN BUSH
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/26/1988
Decision Date 10/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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