The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Replacement Pump Tubing.
| Device ID | K853621 |
| 510k Number | K853621 |
| Device Name: | REPLACEMENT PUMP TUBING |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-29 |
| Decision Date | 1985-12-05 |