COMFEEL PASTE
FDA 510(k) clearance K840362 · decided 1984-11-07
Clearance details
- K-number
- K840362
- Device name
- COMFEEL PASTE
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1984-01-26
- Decision date
- 1984-11-07
- Days to decision
- 286 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coloplast A/S
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.