DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
FDA 510(k) clearance K853558 · decided 1985-09-05
Clearance details
- K-number
- K853558
- Device name
- DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
- Applicant
- American White Cross, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-26
- Decision date
- 1985-09-05
- Days to decision
- 10 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Stamford, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American White Cross
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.