FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
H.R. JAKOBI SURG. INSTR. #10 34/36
K Number: K834178
·
Decision Feb 23, 1984
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
10
Applicant Total
52
Review Days
94
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Basic Information
- Device Name
- H.R. JAKOBI SURG. INSTR. #10 34/36
- K Number
- K834178
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Imm Enterprises , Ltd.
- Date Received
- November 21, 1983
- Decision Date
- February 23, 1984
- Product Code
- GWZ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWZ | Percussor | FDA class 1 | Neurology |
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Other Clearances by Imm Enterprises , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | May 9, 1984 | Substantially Equivalent |
| K841387 | WESTON RECTAL SNARE | May 9, 1984 | Substantially Equivalent |
| K841386 | KOLLMANN URETHRAL DILATOR | May 9, 1984 | Substantially Equivalent |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | May 1, 1984 | Substantially Equivalent |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | Apr 23, 1984 | Substantially Equivalent |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | 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 |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Mar 22, 1984 | Substantially Equivalent |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Mar 22, 1984 | Substantially Equivalent |