EHTOX GASTRIC LAVAGE KIT #2050 & #2070
FDA 510(k) clearance K812648 · decided 1981-09-29
Clearance details
- K-number
- K812648
- Device name
- EHTOX GASTRIC LAVAGE KIT #2050 & #2070
- Applicant
- Ethox Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-17
- Decision date
- 1981-09-29
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA - recall (Z-0271-2012) | Ethox International, Inc. | 2011-11-22 |