The following data is part of a premarket notification filed by Otto Bock Pur Life Science Gmbh with the FDA for Papcone.
Device ID | K083012 |
510k Number | K083012 |
Device Name: | PAPCONE |
Classification | Spatula, Cervical, Cytological |
Applicant | OTTO BOCK PUR LIFE SCIENCE GMBH MAX-NAEDER-STR 15 Duderstadt, Lower Saxony, DE 37115 |
Contact | Christian Schulte |
Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-10-09 |
Decision Date | 2009-04-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PAPCONE 79019480 3233604 Dead/Cancelled |
Otto Bock Schaumstoffwerke GmbH 2005-12-08 |