The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for Fluoroscope Band Bag.
| Device ID | K861785 |
| 510k Number | K861785 |
| Device Name: | FLUOROSCOPE BAND BAG |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | MEDI-PLAST INTL., INC. 8601 DUNWOODY PLACE, N.E. SUITE 330 Atlanta, GA 30338 |
| Contact | Kathleen A Lumberg |
| Correspondent | Kathleen A Lumberg MEDI-PLAST INTL., INC. 8601 DUNWOODY PLACE, N.E. SUITE 330 Atlanta, GA 30338 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-08 |
| Decision Date | 1986-06-13 |