The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for One Step Button(tm).
| Device ID | K910584 |
| 510k Number | K910584 |
| Device Name: | ONE STEP BUTTON(TM) |
| Classification | Tube, Gastro-enterostomy |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Contact | Pat Gilpin |
| Correspondent | Pat Gilpin APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-11 |
| Decision Date | 1991-05-23 |