FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREP TRAY, PREOPERATIVE SKIN
K Number: K781797
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
0
Applicant Total
24
Review Days
16
Basic Information
- Device Name
- PREP TRAY, PREOPERATIVE SKIN
- K Number
- K781797
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
- Date Received
- October 23, 1978
- Decision Date
- November 8, 1978
- Product Code
- OJU
- 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 |
|---|---|---|---|
| OJU | Skin Prep Tray | FDA class 1 | General, Plastic Surgery |
Other Clearances by PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | Dec 10, 1979 | Substantially Equivalent |
| K792141 | CONTINUOUS FLUSH DEVICE | Dec 5, 1979 | Substantially Equivalent |
| K792019 | PHADECODE XA INHIBITOR ASSAY | Nov 5, 1979 | Substantially Equivalent |
| K791773 | VENTILATOR TUBE WITH FILTER | Oct 22, 1979 | Substantially Equivalent |
| K791156 | AMIPAQUE MYELOGRAM TRAY | Jul 30, 1979 | Substantially Equivalent |
| K790896 | TWO-WAY ANESTHESIA FILTER | Jun 5, 1979 | Substantially Equivalent |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | Apr 24, 1979 | Substantially Equivalent |
| K782069 | TRAY, AUXILLARY BLOCK | Jan 4, 1979 | Substantially Equivalent |
| K781680 | MONITORING, PRESSURE KIT | Oct 6, 1978 | Substantially Equivalent |
| K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE | Jun 22, 1978 | Substantially Equivalent |