The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 545g-64 Pahased Array Musculoskeletal Flex Coil Package Model 543ge-64: Phased Array Upper Extrenity Flex Coil Any.
| Device ID | K983109 |
| 510k Number | K983109 |
| Device Name: | MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-04 |
| Decision Date | 1998-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838065383 | K983109 | 000 |
| 00884838065376 | K983109 | 000 |