OMNI-JUG
FDA 510(k) clearance K952200 · decided 1995-06-29
Clearance details
- K-number
- K952200
- Device name
- OMNI-JUG
- Applicant
- Waterstone Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-10
- Decision date
- 1995-06-29
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- KDG
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bethesda, MD, US
- Third-party review
- No
- Expedited review
- No
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| OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (K872092) | Military Engineering, Inc. | 1987-06-23 |
| CHERMEL BONE CHISELS (K842824) | Cher Mel Corp. | 1984-08-02 |
| ANDERSON-NEIVERT OSTEOTOME (K772373) | Edward Weck, Inc. | 1978-03-09 |
| NEIVERT OSTEOTOME (K772376) | Edward Weck, Inc. | 1978-03-09 |
| SILVER OSTEOTOME (K772374) | Edward Weck, Inc. | 1978-03-09 |
| CEMENT EXTRACTION INSTRUMENT SET (K780135) | Orthopedic Equipment Co., Inc. | 1978-01-31 |
Recalls involving this device
No recalls on record reference this clearance.