The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Clip Gun Kit.
Device ID | K050044 |
510k Number | K050044 |
Device Name: | MEDTRONIC CLIP GUN KIT |
Classification | Clip, Scalp |
Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
Contact | Jeffrey Henderson |
Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
Product Code | HBO |
CFR Regulation Number | 882.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-10 |
Decision Date | 2005-02-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169109100 | K050044 | 000 |
00643169647176 | K050044 | 000 |
40643169654325 | K050044 | 000 |
40643169109122 | K050044 | 000 |
20643169647200 | K050044 | 000 |
20643169647187 | K050044 | 000 |
20643169109111 | K050044 | 000 |
20613994845058 | K050044 | 000 |
70721902371591 | K050044 | 000 |