The following data is part of a premarket notification filed by Pinsco Inc. Dba B & L Engineering with the FDA for X12 Sterile Reflective Marker Sphere.
| Device ID | K111443 |
| 510k Number | K111443 |
| Device Name: | X12 STERILE REFLECTIVE MARKER SPHERE |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | PINSCO INC. DBA B & L ENGINEERING 1901 CARNEGIE AVENUE SUITE Q Santa Ana, CA 92705 |
| Contact | Lee A Barnes |
| Correspondent | Lee A Barnes PINSCO INC. DBA B & L ENGINEERING 1901 CARNEGIE AVENUE SUITE Q Santa Ana, CA 92705 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-24 |
| Decision Date | 2011-09-29 |
| Summary: | summary |