FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT
K Number: K895202
·
Decision Sep 15, 1989
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
21
Review Days
28
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Basic Information
- Device Name
- 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT
- K Number
- K895202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Transidyne General Corp.
- Date Received
- August 18, 1989
- Decision Date
- September 15, 1989
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Transidyne General Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | Jul 25, 1996 | Substantially Equivalent |
| K955658 | LACERATION TRAY | Jan 25, 1996 | Substantially Equivalent |
| K950773 | PROPHYLAXIS PACK | Mar 31, 1995 | Unknown |
| K950743 | ORAL PROCEDURE PACK | Mar 31, 1995 | Unknown |
| K950449 | SURGICAL BUR | Mar 1, 1995 | Substantially Equivalent |
| K950403 | SURGICAL SAW BLADES | Feb 21, 1995 | Substantially Equivalent |
| K924811 | I.V. START KIT | Jun 17, 1993 | Unknown |
| K924243 | TRACHEOSTOMY CARE KIT | Jun 16, 1993 | Unknown |
| K922339 | SUTURE REMOVAL KIT | Dec 11, 1992 | Unknown |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Nov 6, 1992 | Unknown |