FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A.D.T. PROCEDURES TRAY
K Number: K812297
·
Decision Sep 28, 1981
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
21
Review Days
45
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Basic Information
- Device Name
- A.D.T. PROCEDURES TRAY
- K Number
- K812297
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- A.D.T. Lab Industries
- Date Received
- August 14, 1981
- Decision Date
- September 28, 1981
- Product Code
- KMJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KMJ | Lubricant, Patient | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMJ), ordered by most recent decision date.
Lubricating Jelly
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE(R) LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
LUBE JELLY SURINGE
FDA 510(k)
FDA Class 1
·General Hospital
DUKAL LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by A.D.T. Lab Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801754 | ADT BONE MARROW ASPIRATION NEEDLE | Aug 20, 1980 | Substantially Equivalent |
| K801753 | ADT BONE MARROW BIOPSY-ASPIR. NEELDE | Aug 20, 1980 | Substantially Equivalent |
| K800410 | ADT BONE MARROW BIOPSY-ASPIRATION TRAY | Apr 28, 1980 | Substantially Equivalent |
| K800417 | ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL | Apr 28, 1980 | Substantially Equivalent |
| K800411 | ASPIRATION TRAY W/FERRIS DISP. ILLINOIS | Apr 28, 1980 | Substantially Equivalent |
| K800418 | ADT DISPOSABLE THIN NEEDLE ASPIRATION | Apr 28, 1980 | Substantially Equivalent |
| K800414 | ADT SOFT TISSUE BIOPSY TRAY | Apr 28, 1980 | Substantially Equivalent |
| K800408 | ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE | Apr 28, 1980 | Substantially Equivalent |
| K800409 | ADT BONE MARROW BIOPSY ASPIRATION TRAY | Apr 28, 1980 | Substantially Equivalent |
| K800412 | ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW | Apr 28, 1980 | Substantially Equivalent |