CONTINENT STOMA SYSTEM & ACCESSORIES
FDA 510(k) clearance K844186 · decided 1985-01-15
Clearance details
- K-number
- K844186
- Device name
- CONTINENT STOMA SYSTEM & ACCESSORIES
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-29
- Decision date
- 1985-01-15
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KBG
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Greenwich, CT, 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 |
|---|---|---|
| REPROCESSED TROCARS (K033591) | Clearmedical, Inc. | 2005-06-03 |
| REPROCESSED DISPOSABLE TROCARS (K013987) | Adven Medical | 2002-03-01 |
Recalls involving this device
No recalls on record reference this clearance.