MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
FDA 510(k) clearance K945238 · decided 1994-12-15
Clearance details
- K-number
- K945238
- Device name
- MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
- Applicant
- F. Walter Hanel GmbH
- Decision
- Substantially Equivalent
- Date received
- 1994-10-27
- Decision date
- 1994-12-15
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- IWQ
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| X-RAY DRAPES (K923099) | Hydro-Med Products, Inc. | 1992-10-15 |
| TECHTON PROTECTIVE PAD (K873038) | Techton, Inc. | 1989-04-03 |
Recalls involving this device
No recalls on record reference this clearance.