The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Simutaneous Fixation & Decalcifying Solution Cal-e.
| Device ID | K850636 |
| 510k Number | K850636 |
| Device Name: | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E |
| Classification | Solution, Decalcifier, Acid Containing |
| Applicant | FISHER SCIENTIFIC CO., LLC. 1 REAGENT LN. Fair Lawn, NJ 07410 |
| Contact | Jack C Mclaughlin |
| Correspondent | Jack C Mclaughlin FISHER SCIENTIFIC CO., LLC. 1 REAGENT LN. Fair Lawn, NJ 07410 |
| Product Code | KDX |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-20 |