The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Clearene, Clearing Agent.
| Device ID | K855109 |
| 510k Number | K855109 |
| Device Name: | CLEARENE, CLEARING AGENT |
| Classification | Agent, Clearing |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Urban,ht (ascp) |
| Correspondent | Urban,ht (ascp) SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | KEM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-01-07 |