The following data is part of a premarket notification filed by Medtronic Inc.,neurological Division with the FDA for Model 3873 1* 8 And Model 3874 1* 8 Compact Test Stimulation Leads.
Device ID | K051773 |
510k Number | K051773 |
Device Name: | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | MEDTRONIC INC.,NEUROLOGICAL DIVISION 710 MEDTRONIC PKWY. Minneapolis, MN 55432 |
Contact | Paula Cordero |
Correspondent | Paula Cordero MEDTRONIC INC.,NEUROLOGICAL DIVISION 710 MEDTRONIC PKWY. Minneapolis, MN 55432 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-01 |
Decision Date | 2005-07-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994756688 | K051773 | 000 |
00613994756664 | K051773 | 000 |
00613994756640 | K051773 | 000 |
00613994756626 | K051773 | 000 |
00643169157415 | K051773 | 000 |
00643169157392 | K051773 | 000 |
00643169157385 | K051773 | 000 |
00643169157361 | K051773 | 000 |