The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Carbon Fiber Couch Insert.
Device ID | K950068 |
510k Number | K950068 |
Device Name: | CARBON FIBER COUCH INSERT |
Classification | Table, Radiologic |
Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
Contact | Donald Riibe |
Correspondent | Donald Riibe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-09 |
Decision Date | 1995-04-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841439108932 | K950068 | 000 |
00841439108925 | K950068 | 000 |
00841439106242 | K950068 | 000 |
00841439106235 | K950068 | 000 |