FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-DERM COUPLING LOTION
K Number: K827885
·
Decision Jan 29, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
35
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- BIO-DERM COUPLING LOTION
- K Number
- K827885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Whs Products, Inc.
- Date Received
- January 1, 1982
- Decision Date
- January 29, 1982
- Product Code
- HGL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
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