DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
FDA 510(k) clearance K921490 · decided 1992-10-05
Clearance details
- K-number
- K921490
- Device name
- DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
- Applicant
- Trinity Laboratories, Inc.
- Decision
- Unknown
- Date received
- 1992-03-30
- Decision date
- 1992-10-05
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salisbury, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.