510(k) K081094
- Device
- OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
- Applicant
- OLYMPIC MEDICAL CORP.
- 510(k) number
- K081094
- Product code
- MEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-20
- Date received
- 2008-04-17
- Regulation
- 880.6992
- Classification name
- Disinfector, Medical Devices
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE HESLER
- Address
- 5900 First Ave. S. Seattle WA US 98108 98108
FDA Registration Numbers#
- 3010208143
- 3001061128
- 9680353
- 3014268952
- 8021896
- 3010392991
- 8043629
- 3022516928
- 3030516433
- 3012006473
- 3005544459
- 3018520804
- 3010834934
- 3027509245
- 3021244152
- 9617134
- 3010653034
- 9616031
- 3011554142
- 3008344687
- 3012776156
- 2225311
- 3015977541
- 3005273623
- 3031563141
- 3015136927
- 3042250638
- 3017847344
- 3029300415
- 3006563173
- 1056339
- 3006446479
- 9680101
- 3002821232
- 3017293064
- 3030536467
- 3030733800
- 3006654680
- 3021233712
- 3043861826
- 1825014
Source Documents#
Other 510(k) Records For Product Code MEC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911120 | DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 | Hamo USA, Inc. | 1994-02-03 |
Legacy Summary#
summary
FDA Review#
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