FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNIVERSALLY ADJUSTABLE ARMBOARD
K Number: K882524
·
Decision Jul 8, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
17
Review Days
21
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Basic Information
- Device Name
- UNIVERSALLY ADJUSTABLE ARMBOARD
- K Number
- K882524
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3910
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Karlin Technology, Inc.
- Date Received
- June 17, 1988
- Decision Date
- July 8, 1988
- Product Code
- BTX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTX | Board, Arm (With Cover), Sterile | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTX), ordered by most recent decision date.
BABY BOARD
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4/1 ARMBOARD
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ALLEN PRONE ARMBOARD
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ALLEN LATERAL ARMBOARD
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BOARD, ARM (WITH COVER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARMBOARD AND THE BOARD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Karlin Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903969 | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET | Sep 5, 1990 | Substantially Equivalent |
| K893201 | BONE PLATE | Apr 4, 1990 | Substantially Equivalent |
| K893203 | BONE SCREW | Apr 4, 1990 | Substantially Equivalent |
| K882525 | SPINAL MICROKNIFE | Sep 22, 1988 | Substantially Equivalent |
| K882519 | X-RAY MARKER | Aug 9, 1988 | Substantially Equivalent |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | Jul 18, 1988 | Substantially Equivalent |
| K882073 | SPINAL NEEDLE | Jul 18, 1988 | Substantially Equivalent |
| K882069 | SPINAL DISTRACTORS, SPANNERS | Jun 17, 1988 | Substantially Equivalent |
| K882072 | ORTHOPAEDIC AND SPINAL RING CURRETTES | Jun 17, 1988 | Substantially Equivalent |
| K882077 | MICRODISCECTOMY CURRETTES | Jun 17, 1988 | Substantially Equivalent |