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Found 2 results
510(k) Data Aggregation
K Number
K093266Device Name
MAM COOLER
Manufacturer
MAM INTERNATIONAL AG
Date Cleared
2010-07-27
(281 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
Applicant Name (Manufacturer) :
MAM INTERNATIONAL AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K092781Device Name
MAM TWISTER
Manufacturer
MAM INTERNATIONAL AG
Date Cleared
2010-06-23
(286 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
Applicant Name (Manufacturer) :
MAM INTERNATIONAL AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
Device Description
Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPS1A Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP, DINP, DIDP, DIDP, DIOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9
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