PAPCONE
Spatula, Cervical, Cytological
OTTO BOCK PUR LIFE SCIENCE GMBH
The following data is part of a premarket notification filed by Otto Bock Pur Life Science Gmbh with the FDA for Papcone.
Pre-market Notification Details
| 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 |
Trademark Results [PAPCONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAPCONE 79019480 3233604 Dead/Cancelled |
Otto Bock Schaumstoffwerke GmbH 2005-12-08 |
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