CALASEPT PASTE
FDA 510(k) clearance K895508 · decided 1989-12-08
Clearance details
- K-number
- K895508
- Device name
- CALASEPT PASTE
- Applicant
- Js Dental Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-11
- Decision date
- 1989-12-08
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- EJK
- Device class
- 2
- Regulation number
- 872.3250
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ridgefield, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.