SAWYER FIRST AID KIT
FDA 510(k) clearance K842015 · decided 1984-07-06
Clearance details
- K-number
- K842015
- Device name
- SAWYER FIRST AID KIT
- Applicant
- Saffeta, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-18
- Decision date
- 1984-07-06
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- KYP
- Device class
- 1
- Regulation number
- 880.5740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 (K883839) | Marlo Surgical Technology | 1988-12-09 |
| DR. HESSEL'S INSECT POISON REMOVER (K844048) | Medie Group | 1985-01-23 |
| LOPEZ-HORN CARRIER (K831312) | Chiron Vision Corp. | 1983-05-25 |
Recalls involving this device
No recalls on record reference this clearance.