The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Delta-tech(tm) Cast Removal System.
| Device ID | K895861 |
| 510k Number | K895861 |
| Device Name: | DELTA-TECH(TM) CAST REMOVAL SYSTEM |
| Classification | Instrument, Cast Removal, Ac-powered |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | LGH |
| CFR Regulation Number | 888.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-10-19 |