BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

BARD INTERVENTIONAL PRODUCTS DIV.

The following data is part of a premarket notification filed by Bard Interventional Products Div. with the FDA for Bard Proforma And Apollo Pre-curved Papillotomes.

Pre-market Notification Details

Device IDK982557
510k NumberK982557
Device Name:BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant BARD INTERVENTIONAL PRODUCTS DIV. 129 CONCORD RD. P.O. BOX 7031 Billerica,  MA  01821 -7031
ContactMarion Gordon
CorrespondentMarion Gordon
BARD INTERVENTIONAL PRODUCTS DIV. 129 CONCORD RD. P.O. BOX 7031 Billerica,  MA  01821 -7031
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-22
Decision Date1998-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00653405051681 K982557 000
20653405051623 K982557 000
20653405051616 K982557 000
20653405051609 K982557 000
20653405051593 K982557 000
20653405051548 K982557 000
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20653405986451 K982557 000
20653405986444 K982557 000
20653405986420 K982557 000
10653405006459 K982557 000
20653405051630 K982557 000
20653405051647 K982557 000
20653405051654 K982557 000
00653405051582 K982557 000
00653405051575 K982557 000
00653405051568 K982557 000
00653405051551 K982557 000
40653405014363 K982557 000
30653405014366 K982557 000
20653405051722 K982557 000
20653405051715 K982557 000
20653405051678 K982557 000
20653405051661 K982557 000
10653405006428 K982557 000

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