BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ACE CUSTOM SURGICAL PACK

    K Number: K922648 · Decision Mar 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    21
    Review Days
    290

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    Basic Information

    Device Name
    ACE CUSTOM SURGICAL PACK
    K Number
    K922648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    June 3, 1992
    Decision Date
    March 20, 1993
    Product Code
    LRO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRO General Surgery Tray

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    Other Clearances by Ace Surgical Supply Co., Inc.

    K Number Device Name
    K093518 ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
    K092594 ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
    K073343 ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
    K080074 ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
    K061397 ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
    K051381 ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
    K041759 ACE CONNECT INTERNAL CONNECTION
    K021244 ACE HA SCREW DENTAL IMPLANT SYSTEM
    K002075 ACE SDS 3.75MM SCREW DENTAL IMPLANT
    K990140 NORMED BONE TRANSPORT
    Search all 21 clearances from Ace Surgical Supply Co., Inc. →