FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

EAGLE PAC/VISIBLE SEAL

K Number: K781699 · Decision Oct 24, 1978
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
36
Review Days
13

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Basic Information

Device Name
EAGLE PAC/VISIBLE SEAL
K Number
K781699
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6850
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
American Sterilizer Co.
Date Received
October 11, 1978
Decision Date
October 24, 1978
Product Code
KCT
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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Other Clearances by American Sterilizer Co.

K Number Device Name
K943288 AMSCO SQ240 SURGICAL LIGHT
K931872 THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K922485 CHEMDI-VHP CHEMICAL INDICATOR
K930493 QUANTUM 3080 SURGICAL TABLE
K905816 ORTHOVISION TABLE
K896674 AMSCO QUANTUM LIGHT
K895164 EAGLE DS
K882660 GENERAL SURGICAL TABLE AND ACCESSORIES
K880198 GEMINI SURGICAL LIGHT
K864846 RADIOGRAPHIC - LEG SECTION
Search all 36 clearances from American Sterilizer Co. →