The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Spetzler Ti 100 Aneurysm Clip.
| Device ID | K955064 |
| 510k Number | K955064 |
| Device Name: | SPETZLER TI 100 ANEURYSM CLIP |
| Classification | Clip, Aneurysm |
| Applicant | ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Contact | Michael Lang |
| Correspondent | Michael Lang ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1996-10-17 |
| Summary: | summary |