The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Cannulas For Hema-tek I & Kk Slide Stainers.
Device ID | K850157 |
510k Number | K850157 |
Device Name: | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS |
Classification | Slide Stainer, Automated |
Applicant | SHABAN MFG. CO. 3052 METRO PKWY. Fort Myers, FL 33901 |
Contact | Barbara H Sneade |
Correspondent | Barbara H Sneade SHABAN MFG. CO. 3052 METRO PKWY. Fort Myers, FL 33901 |
Product Code | KPA |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-15 |
Decision Date | 1985-02-27 |