FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEADED X-RAY APRON
K Number: K832601
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
5
Applicant Total
21
Review Days
58
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Basic Information
- Device Name
- LEADED X-RAY APRON
- K Number
- K832601
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- E.M. Adams
- Date Received
- August 2, 1983
- Decision Date
- September 29, 1983
- Product Code
- EAJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EAJ | Apron, Leaded | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAJ), ordered by most recent decision date.
LEAD APRON
FDA 510(k)
FDA Class 1
·Radiology
RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR
FDA 510(k)
FDA Class 1
·Radiology
X-RAY APRON
FDA 510(k)
FDA Class 1
·Radiology
LEAD APRON CADDY
FDA 510(k)
FDA Class 1
·Radiology
THYROID PROTECTIVE COLLAR
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by E.M. Adams
| K Number | Device Name | ||
|---|---|---|---|
| K905173 | SPLASH GUARD | Apr 25, 1991 | Substantially Equivalent |
| K910468 | STERILE DISPOSABLE DRAPE(S) | Mar 21, 1991 | Substantially Equivalent |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | Nov 23, 1987 | Substantially Equivalent |
| K850063 | INSTRUMENT POCKET | Feb 21, 1985 | Substantially Equivalent |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | Jan 10, 1985 | Substantially Equivalent |
| K843783 | WET PACK | Dec 19, 1984 | Substantially Equivalent |
| K843782 | DRY TRAY | Dec 13, 1984 | Substantially Equivalent |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | Oct 23, 1984 | Substantially Equivalent |
| K843115 | STERILE SOLUTION BOWL | Sep 7, 1984 | Substantially Equivalent |
| K843116 | DISPOSABLE SKIN MARKING PEN | Aug 17, 1984 | Substantially Equivalent |