53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
FDA 510(k) clearance K851797 · decided 1985-05-23
Clearance details
- K-number
- K851797
- Device name
- 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-05-23
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- FFQ
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.