RIGID TEACHING ATTACHMENT
FDA 510(k) clearance K770349 · decided 1977-03-07
Clearance details
- K-number
- K770349
- Device name
- RIGID TEACHING ATTACHMENT
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-22
- Decision date
- 1977-03-07
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HWN
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| AOT EXTERNAL COMPRESS DEVICE (K854241) | Advanced Ortho-Technology, Inc. | 1986-03-03 |
| ARICULATED TENSION DEVICE SYNTHES TEN (K792253) | Synthes (Usa) | 1979-12-05 |
| FLORIO CPC BAND (K760970) | Richard'S Medical Equip., Inc. | 1976-11-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |