The following data is part of a premarket notification filed by Specialty Medical Sales, Inc. with the FDA for Non-invasive Tubing.
| Device ID | K921450 |
| 510k Number | K921450 |
| Device Name: | NON-INVASIVE TUBING |
| Classification | Tubing, Fluid Delivery |
| Applicant | SPECIALTY MEDICAL SALES, INC. 10 MANOR PKWY. Salem, NH 03079 |
| Contact | Michael Merchant |
| Correspondent | Michael Merchant SPECIALTY MEDICAL SALES, INC. 10 MANOR PKWY. Salem, NH 03079 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-26 |
| Decision Date | 1993-02-05 |