The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Pump Tube Sets For Hema-tek I & Ii Slide Stainers.
| Device ID | K850333 |
| 510k Number | K850333 |
| Device Name: | PUMP TUBE SETS FOR HEMA-TEK I & II 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 | 1985-01-28 |
| Decision Date | 1985-02-27 |