The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Xylene.
| Device ID | K812847 | 
| 510k Number | K812847 | 
| Device Name: | XYLENE | 
| Classification | Agent, Clearing | 
| Applicant | RICHARD-ALLAN MEDICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | KEM | 
| CFR Regulation Number | 864.4010 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1981-10-09 | 
| Decision Date | 1981-10-29 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  XYLENE  72238302  0817628 Dead/Expired | SANDOZ, INC. 1966-02-07 |