The following data is part of a premarket notification filed by Lic-orthion with the FDA for Adam (absorbent Incontinence Shield).
| Device ID | K854729 |
| 510k Number | K854729 |
| Device Name: | ADAM (ABSORBENT INCONTINENCE SHIELD) |
| Classification | Garment, Protective, For Incontinence |
| Applicant | LIC-ORTHION RODNEY R. MUNSEY 2101 L STREET N.W. Washington, DC 20037 |
| Contact | C/odickstein Shapiro |
| Correspondent | C/odickstein Shapiro LIC-ORTHION RODNEY R. MUNSEY 2101 L STREET N.W. Washington, DC 20037 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-25 |
| Decision Date | 1986-02-06 |