PERFECT, ENT SET, PRAKTIKANT, DE LUXE

Otoscope

RUDOLF RIESTER GMBH & CO. KG

The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Perfect, Ent Set, Praktikant, De Luxe.

Pre-market Notification Details

• Device ID: K950913
• 510k Number: K950913
• Device Name: PERFECT, ENT SET, PRAKTIKANT, DE LUXE
• Classification: Otoscope
• Applicant: RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE
• Contact: Karlheinz Riester
• Correspondent: Karlheinz Riester; RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE
• Product Code: ERA
• CFR Regulation Number: 874.4770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-02-23
• Decision Date: 1995-05-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04045396010765	K950913	000
00634782076320	K950913	000
00634782076337	K950913	000
00634782076818	K950913	000
00634782076825	K950913	000
00634782076832	K950913	000
00634782076849	K950913	000
00634782076856	K950913	000
00634782076863	K950913	000
00634782076870	K950913	000
00634782076887	K950913	000
00634782076313	K950913	000
04045396211612	K950913	000
04045396211605	K950913	000
04045396010796	K950913	000
04045396129962	K950913	000
04045396141322	K950913	000
04045396141339	K950913	000
04045396147140	K950913	000
04045396147157	K950913	000
04045396147164	K950913	000
04045396182639	K950913	000
04045396211568	K950913	000
04045396211599	K950913	000
00634782076894	K950913	000
00634782076900	K950913	000
00634782087555	K950913	000
00634782087562	K950913	000
00634782087579	K950913	000
00634782087586	K950913	000
00634782087593	K950913	000
00634782087609	K950913	000
00634782087616	K950913	000
00634782087623	K950913	000
00634782087630	K950913	000
00634782087647	K950913	000
00634782087548	K950913	000
00634782087531	K950913	000
00634782087524	K950913	000
00634782076917	K950913	000
00634782076924	K950913	000
00634782076931	K950913	000
00634782076948	K950913	000
00634782076955	K950913	000
00634782076962	K950913	000
00634782076979	K950913	000
00634782076986	K950913	000
00634782087500	K950913	000
00634782087517	K950913	000
00634782087654	K950913	000