510(k) K945238
- Device
- MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
- Applicant
- F. WALTER HANEL GMBH
- 510(k) number
- K945238
- Product code
- IWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-12-15
- Date received
- 1994-10-27
- Regulation
- 892.6500
- Classification name
- Curtain, Protective, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY M MCNAMARA
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3022870871
- 3018269545
- 2431224
- 3007369190
- 3007050292
- 2244478
- 3037012186
- 3020118
- 3003696170
- 3010373263
- 1225473
- 3031582440
- 2032841
- 3006897996
- 3013846070
- 3017181414
- 1053541
- 3016170492
Source Documents#
Other 510(k) Records For Product Code IWQ #
Legacy Summary#
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FDA Review#
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