The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Blue Ribbon Paraffin Infiltration/embedding Med..
| Device ID | K861270 |
| 510k Number | K861270 |
| Device Name: | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. |
| Classification | Formulations, Paraffin, All |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Ht (ascp) |
| Correspondent | Ht (ascp) SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | KEO |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-04 |
| Decision Date | 1986-04-11 |