PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE

Tube, Tracheal (w/wo Connector)

PARKERMEDICALINC

The following data is part of a premarket notification filed by Parkermedicalinc with the FDA for Parker Flex- Tip Oral/nasa Intubation Tube.

Pre-market Notification Details

Device IDK100546
510k NumberK100546
Device Name:PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant PARKERMEDICALINC 4655 KIRKWOOD COURT Boulder,  CO  80301
ContactLewis Ward
CorrespondentLewis Ward
PARKERMEDICALINC 4655 KIRKWOOD COURT Boulder,  CO  80301
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-25
Decision Date2010-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20607411954607 K100546 000
00607411954474 K100546 000
20607411954461 K100546 000
20607411954454 K100546 000
20607411954447 K100546 000
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20607411954423 K100546 000
20607411954416 K100546 000
20607411954409 K100546 000
10607411954396 K100546 000
20607411954386 K100546 000
20607411954485 K100546 000
20607411954492 K100546 000
20607411954591 K100546 000
20607411954584 K100546 000
20607411954577 K100546 000
20607411954560 K100546 000
20607411954553 K100546 000
20607411654545 K100546 000
20607411954539 K100546 000
20607411954522 K100546 000
20607411954515 K100546 000
20607411954508 K100546 000
20607411954379 K100546 000

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