MAGNETIC RETENTION UNIT
FDA 510(k) clearance K811237 · decided 1981-06-16
Clearance details
- K-number
- K811237
- Device name
- MAGNETIC RETENTION UNIT
- Applicant
- Universiti Malaya
- Decision
- Substantially Equivalent
- Date received
- 1981-05-04
- Decision date
- 1981-06-16
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- ECG
- Device class
- 1
- Regulation number
- 872.6710
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Universiti Malaya
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 |
|---|---|---|
| EAGLE DS (K895164) | American Sterilizer Co. | 1989-11-17 |
| CITOMAT AUTOCLAVES (K843234) | Lic-Orthion | 1984-10-25 |
| ENDODONTIC POST SYSTEMS (K810977) | Preat Corp. | 1981-05-13 |
| NEY EQUI-HINGE (K790290) | Deringer-Ney, Inc. | 1979-04-10 |
| BAR & RIDER, SCREWS, TUBES (K790078) | Eurodent, Inc. | 1979-02-27 |
| STEAM STERILIZER (K771266) | Amsco Hospital Products Co. | 1977-08-02 |
Recalls involving this device
No recalls on record reference this clearance.