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 ID: K982557
• 510k Number: K982557
• Device Name: BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
• Classification: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Applicant: BARD INTERVENTIONAL PRODUCTS DIV. 129 CONCORD RD. P.O. BOX 7031 Billerica, MA 01821 -7031
• Contact: Marion Gordon
• Correspondent: Marion Gordon; BARD INTERVENTIONAL PRODUCTS DIV. 129 CONCORD RD. P.O. BOX 7031 Billerica, MA 01821 -7031
• Product Code: KNS
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-22
• Decision Date: 1998-09-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00653405051681	K982557	000
20653405051616	K982557	000
20653405051609	K982557	000
20653405051593	K982557	000
20653405051548	K982557	000
20653405051531	K982557	000
20653405986451	K982557	000
20653405986444	K982557	000
20653405986420	K982557	000
10653405006459	K982557	000
10653405006428	K982557	000
10653405051565	K982557	000
10653405051558	K982557	000
20653405051623	K982557	000
20653405051630	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
20653405051654	K982557	000
20653405051647	K982557	000
20653405986437	K982557	000