510(k) K883619
- Device
- Medicated Covering Coated W/1.0% Hydro Adhes. Gel
- Applicant
- MINNETONKA, INC.
- 510(k) number
- K883619
- Product code
- SEK
- Decision
- Substantially Equivalent for Some Indications (SN)
- Decision date
- 1989-09-01
- Date received
- 1988-08-24
- Classification name
- Wound Dressings With Hydrocortisone
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD E REEVER
- Address
- P.O. Box 1a Minnetonka MN US 55343 55343
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SEK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883566 | MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL | Minnetonka, Inc. | 1989-09-01 |