The following data is part of a premarket notification filed by Mega Dyne Medical Products, Inc. with the FDA for General Hospital Tubing Clamp (non-electric).
| Device ID | K911586 |
| 510k Number | K911586 |
| Device Name: | GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) |
| Classification | Tube, Aspirating, Flexible, Connecting |
| Applicant | MEGA DYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Contact | Drew D Weaver |
| Correspondent | Drew D Weaver MEGA DYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Product Code | BYY |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-07-02 |