FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAT 13-CLINICAL CHEMISTRY DEVICES
K Number: K840317
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
72
Applicant Total
52
Review Days
48
Basic Information
- Device Name
- CAT 13-CLINICAL CHEMISTRY DEVICES
- K Number
- K840317
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- IMM ENTERPRISES LTD.
- Date Received
- January 24, 1984
- Decision Date
- March 12, 1984
- Product Code
- HTD
- 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 |
|---|---|---|---|
| HTD | Forceps | FDA class 1 | General, Plastic Surgery |
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Other Clearances by IMM ENTERPRISES LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K841386 | KOLLMANN URETHRAL DILATOR | May 9, 1984 | Substantially Equivalent |
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | May 9, 1984 | Substantially Equivalent |
| K841387 | WESTON RECTAL SNARE | May 9, 1984 | Substantially Equivalent |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | May 1, 1984 | Substantially Equivalent |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | Apr 23, 1984 | Substantially Equivalent |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | Apr 23, 1984 | Substantially Equivalent |
| K840312 | CAT. 8 DENTAL DEVICES | Apr 5, 1984 | Substantially Equivalent |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Apr 4, 1984 | Substantially Equivalent |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Mar 22, 1984 | Substantially Equivalent |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Mar 22, 1984 | Substantially Equivalent |