The following data is part of a premarket notification filed by Parabasetec, Gmbh with the FDA for Paragolfer.
Device ID | K060936 |
510k Number | K060936 |
Device Name: | PARAGOLFER |
Classification | Wheelchair, Standup |
Applicant | PARABASETEC, GMBH 2247 JENNIFER LANE St. Paul, MN 55109 |
Contact | William Jackson |
Correspondent | William Jackson PARABASETEC, GMBH 2247 JENNIFER LANE St. Paul, MN 55109 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-05 |
Decision Date | 2006-08-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04032767817948 | K060936 | 000 |
04032767402526 | K060936 | 000 |
04032767048397 | K060936 | 000 |
04064406193656 | K060936 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PARAGOLFER 79066956 3807159 Dead/Cancelled |
Otto Bock HealthCare GmbH 2009-02-23 |
PARAGOLFER 76711427 4200403 Live/Registered |
Otto Bock HealthCare GmbH 2009-02-23 |