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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Drill, Ligament
510(k) Number K881378
Device Name PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
Applicant
Pfizer, Inc.
Eastern Pt. Rd.
Groton,  CT  06340
Applicant Contact JOSEPH E LAPTEWICZ
Correspondent
Pfizer, Inc.
Eastern Pt. Rd.
Groton,  CT  06340
Correspondent Contact JOSEPH E LAPTEWICZ
Regulation Number878.4820
Classification Product Code
LXI  
Date Received04/01/1988
Decision Date 06/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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