PROVOX VEGA, MODEL 8130-8135

Prosthesis, Laryngeal (taub)

ATOS MEDICAL AB

The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Vega, Model 8130-8135.

Pre-market Notification Details

• Device ID: K090455
• 510k Number: K090455
• Device Name: PROVOX VEGA, MODEL 8130-8135
• Classification: Prosthesis, Laryngeal (taub)
• Applicant: ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-24222
• Contact: Ferenc Dahner
• Correspondent: Ferenc Dahner; ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-24222
• Product Code: EWL
• CFR Regulation Number: 874.3730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-23
• Decision Date: 2009-06-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07331791010095	K090455	000
07331791010422	K090455	000
07331791010439	K090455	000
07331791010446	K090455	000
07331791010453	K090455	000
07331791010460	K090455	000
07331791010477	K090455	000
07331791010484	K090455	000
07331791010491	K090455	000
07331791010507	K090455	000
07331791010514	K090455	000
07331791010521	K090455	000
07331791010538	K090455	000
07331791010545	K090455	000
07331791010552	K090455	000
07331791010569	K090455	000
07331791010576	K090455	000
07331791010415	K090455	000
07331791010262	K090455	000
07331791010101	K090455	000
07331791010118	K090455	000
07331791010125	K090455	000
07331791010132	K090455	000
07331791010149	K090455	000
07331791010156	K090455	000
07331791010163	K090455	000
07331791010170	K090455	000
07331791010187	K090455	000
07331791010194	K090455	000
07331791010200	K090455	000
07331791010217	K090455	000
07331791010224	K090455	000
07331791010231	K090455	000
07331791010248	K090455	000
07331791010255	K090455	000
07331791010583	K090455	000
07331791010743	K090455	000
07331791010934	K090455	000
07331791010941	K090455	000
07331791010958	K090455	000
07331791010965	K090455	000
07331791010972	K090455	000
07331791010989	K090455	000
07331791010996	K090455	000
07331791011009	K090455	000
07331791011016	K090455	000
07331791011023	K090455	000
07331791011030	K090455	000
07331791011047	K090455	000
07331791011054	K090455	000
07331791011061	K090455	000
07331791011078	K090455	000
07331791011085	K090455	000
07331791010927	K090455	000
07331791010910	K090455	000
07331791010750	K090455	000
07331791010767	K090455	000
07331791010774	K090455	000
07331791010781	K090455	000
07331791010798	K090455	000
07331791010804	K090455	000
07331791010811	K090455	000
07331791010828	K090455	000
07331791010835	K090455	000
07331791010842	K090455	000
07331791010859	K090455	000
07331791010866	K090455	000
07331791010873	K090455	000
07331791010880	K090455	000
07331791010897	K090455	000
07331791010903	K090455	000
07331791011092	K090455	000