SUBDERM TM
FDA 510(k) clearance K853635 · decided 1985-12-20
Clearance details
- K-number
- K853635
- Device name
- SUBDERM TM
- Applicant
- General Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-30
- Decision date
- 1985-12-20
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| TULA IONTOPHORESIS SYSTEM (K110636) | Acclarent, Inc. | 2011-06-16 |
| ACTHYDERM (K083016) | Microlab Americas, Inc. | 2009-06-16 |
Recalls involving this device
No recalls on record reference this clearance.