The following data is part of a premarket notification filed by Solo Pak Laboratories with the FDA for Max-i-probe Handpiece.
| Device ID | K851944 |
| 510k Number | K851944 |
| Device Name: | MAX-I-PROBE HANDPIECE |
| Classification | Syringe, Periodontic, Endodontic, Irrigating |
| Applicant | SOLO PAK LABORATORIES 3727 MT. PROSPECT RD. Franklin Park, IL 60131 |
| Contact | Thomas F Willer |
| Correspondent | Thomas F Willer SOLO PAK LABORATORIES 3727 MT. PROSPECT RD. Franklin Park, IL 60131 |
| Product Code | EIC |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-03 |
| Decision Date | 1985-07-01 |