PAPILLION PROCTOSCOPE
FDA 510(k) clearance K914784 · decided 1992-06-05
Clearance details
- K-number
- K914784
- Device name
- PAPILLION PROCTOSCOPE
- Applicant
- Oldelft Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1991-10-23
- Decision date
- 1992-06-05
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- KQA
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Fairfax, VA, 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 |
|---|---|---|
| PHILIPS RT250 COLLIMATOR (PK8050) (K885126) | Perkins Mfg. Co. | 1989-06-01 |
| THE MCP-70-SE SYSTEM (K844180) | Ellis Pharmaceutical Consulting, Inc. | 1985-02-01 |
| COLLIMATOR, BILATERIAL (K790168) | Cmsi | 1979-02-15 |
Recalls involving this device
No recalls on record reference this clearance.