The following data is part of a premarket notification filed by Infinitech, Inc. with the FDA for Infinitech Bullet Endo Illuminated Pick Manipulator.
| Device ID | K972506 |
| 510k Number | K972506 |
| Device Name: | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR |
| Classification | Transilluminator, Ac-powered |
| Applicant | INFINITECH, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman INFINITECH, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | HJM |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-10-01 |
| Summary: | summary |