SELF SEAL STERILIZATION POUCH

Wrap, Sterilization

SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.

The following data is part of a premarket notification filed by Shanghai Jianzhong Medical Packaging Co., Ltd. with the FDA for Self Seal Sterilization Pouch.

Pre-market Notification Details

Device IDK071886
510k NumberK071886
Device Name:SELF SEAL STERILIZATION POUCH
ClassificationWrap, Sterilization
Applicant SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. 1558-1-2101 SOUTH XIZANG ROAD Shanghai,  CN 200011
ContactLongfu Song
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-07-09
Decision Date2007-12-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20810132800232 K071886 000
20810132800317 K071886 000
20810132800331 K071886 000
00810132800375 K071886 000
20686864044783 K071886 000
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20810132800300 K071886 000
20810132800294 K071886 000
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00810132800245 K071886 000
00810132800269 K071886 000
00810132800276 K071886 000
00810132800283 K071886 000
20686864044844 K071886 000
D883AA01403 K071886 000
D883AA01603 K071886 000
20612479196586 K071886 000
20612479196609 K071886 000
20612479196623 K071886 000
20612479196647 K071886 000
20612479196661 K071886 000
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20612479203796 K071886 000
20612479203819 K071886 000
20612479203833 K071886 000
20612479196562 K071886 000
20612479196548 K071886 000
D883AA01101 K071886 000
D883AA01111 K071886 000
D883AA01121 K071886 000
D883AA01131 K071886 000
D883AA01141 K071886 000
D883AA01151 K071886 000
D883AA01161 K071886 000
D883AA01171 K071886 000
D883AA01181 K071886 000
20612479203857 K071886 000

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