The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Decalcifier I.
| Device ID | K841488 |
| 510k Number | K841488 |
| Device Name: | DECALCIFIER I |
| Classification | Solution, Decalcifier, Acid Containing |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDX |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-10 |
| Decision Date | 1984-05-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DECALCIFIER I 77751175 3809407 Live/Registered |
Leica Biosystems Richmond, Inc. 2009-06-03 |
![]() DECALCIFIER I 73323362 1302151 Live/Registered |
Surgipath Medical Industries, Inc. 1981-08-13 |