AOT EXTERNAL COMPRESS DEVICE
FDA 510(k) clearance K854241 · decided 1986-03-03
Clearance details
- K-number
- K854241
- Device name
- AOT EXTERNAL COMPRESS DEVICE
- Applicant
- Advanced Ortho-Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-21
- Decision date
- 1986-03-03
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- HWN
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tuckahoe, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARICULATED TENSION DEVICE SYNTHES TEN (K792253) | Synthes (Usa) | 1979-12-05 |
| RIGID TEACHING ATTACHMENT (K770349) | Richard Wolf Medical Instruments Corp. | 1977-03-07 |
| FLORIO CPC BAND (K760970) | Richard'S Medical Equip., Inc. | 1976-11-23 |
Recalls involving this device
No recalls on record reference this clearance.