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 |