SR-ISOCETTE
FDA 510(k) clearance K811665 · decided 1981-07-15
Clearance details
- K-number
- K811665
- Device name
- SR-ISOCETTE
- Applicant
- J. Aderer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-15
- Decision date
- 1981-07-15
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- ELK
- Device class
- 1
- Regulation number
- 872.3910
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch J. Aderer
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.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERMOMETER JARS AND CAPS (K760909) | Plastics/Packaging | 1976-12-30 |
Recalls involving this device
No recalls on record reference this clearance.