The following data is part of a premarket notification filed by Stereotactic Medical Systems, Inc. with the FDA for Compass(tm) Stereotactic Retractor System.
| Device ID | K896156 |
| 510k Number | K896156 |
| Device Name: | COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | STEREOTACTIC MEDICAL SYSTEMS, INC. 11 SENECA TURPIKE New Harford, NY 13413 |
| Contact | Bruce A Kall |
| Correspondent | Bruce A Kall STEREOTACTIC MEDICAL SYSTEMS, INC. 11 SENECA TURPIKE New Harford, NY 13413 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1989-12-06 |