MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
FDA 510(k) clearance K883619 · decided 1989-09-01
Clearance details
- K-number
- K883619
- Device name
- MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
- Applicant
- Minnetonka, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1988-08-24
- Decision date
- 1989-09-01
- Days to decision
- 373 days
- Clearance type
- Traditional
- Product code
- SEK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Minnetonka, MN, 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 |
|---|---|---|
| MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL (K883566) | Minnetonka, Inc. | 1989-09-01 |
Recalls involving this device
No recalls on record reference this clearance.