DECALCIFIER II
Solution, Decalcifier, Acid Containing
SURGIPATH
The following data is part of a premarket notification filed by Surgipath with the FDA for Decalcifier Ii.
Pre-market Notification Details
| Device ID | K810836 |
| 510k Number | K810836 |
| Device Name: | DECALCIFIER II |
| Classification | Solution, Decalcifier, Acid Containing |
| Applicant | SURGIPATH 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 | 1981-03-26 |
| Decision Date | 1981-04-23 |
Trademark Results [DECALCIFIER II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DECALCIFIER II 77751191 3809408 Live/Registered |
Leica Biosystems Richmond, Inc. 2009-06-03 |
 DECALCIFIER II 73323361 1302150 Live/Registered |
Surgipath Medical Industries, Inc. 1981-08-13 |
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