DIALYSIS, JET SYSTEM
FDA 510(k) clearance K770331 · decided 1977-04-20
Clearance details
- K-number
- K770331
- Device name
- DIALYSIS, JET SYSTEM
- Applicant
- Janneck Ent. of Texas
- Decision
- Substantially Equivalent
- Date received
- 1977-02-17
- Decision date
- 1977-04-20
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- EKP
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- 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 |
|---|---|---|
| REAMER TYPE K ENDODONTIC (K823686) | United Dental Mfg., Inc. | 1982-12-28 |
| ROOT CANAL REAMERS, TYPE K (K822620) | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 |
| ENDEX REAMERS PULP CANAL, ENDODONTIC (K800291) | Ipco Corp. | 1980-02-19 |
| ENDODONTIC INSTRUMENTS, R&R CUTWELL (K770598) | Ransom and Randolph | 1977-04-05 |
| ROOT CANAL FILES & REAMERS (K770367) | Cemco Tool Co., Inc. | 1977-03-01 |
Recalls involving this device
No recalls on record reference this clearance.