PROFILE SWAB CAT.#5273 & 5274
FDA 510(k) clearance K802004 · decided 1980-09-16
Clearance details
- K-number
- K802004
- Device name
- PROFILE SWAB CAT.#5273 & 5274
- Applicant
- Pollak (Intl.), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-20
- Decision date
- 1980-09-16
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KXG
- Device class
- 1
- Regulation number
- 880.6025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.