FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
CARAPACE SUTURE REMOVAL TRAYS
K Number: K931819
·
Decision Jan 26, 1994
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
22
Review Days
293
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Basic Information
- Device Name
- CARAPACE SUTURE REMOVAL TRAYS
- K Number
- K931819
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Carapace, Inc.
- Date Received
- April 8, 1993
- Decision Date
- January 26, 1994
- Product Code
- IRO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
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Other Clearances by Carapace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931722 | CARAPACE LABOR AND DELIVERY SETS | Mar 23, 1994 | Unknown |
| K931822 | CARAPACE PELVIC EXAM TRAYS | Mar 7, 1994 | Unknown |
| K931729 | I.V. START KIT | Feb 22, 1994 | Unknown |
| K931820 | CARAPACE STILLWATER BOWL SET | Feb 7, 1994 | Unknown |
| K931669 | CARAPACE DEBRIDEMENT KITS | Feb 7, 1994 | Unknown |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Feb 4, 1994 | Unknown |
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Jan 26, 1994 | Unknown |
| K931670 | CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS | Jan 25, 1994 | Substantially Equivalent |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Jan 25, 1994 | Unknown |