510(k) K780153
- Device
- HOUSE SUCTION IRRIGATOR
- Applicant
- EDWARD WECK, INC.
- 510(k) number
- K780153
- Product code
- JYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-02-02
- Date received
- 1978-01-30
- Regulation
- 878.4800
- Classification name
- Cannula, Ear
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1926681
- 3014615697
- 8010372
- 3008902714
- 3008338766
- 3003418325
- 1836161
- 9613926
- 1923569
- 1421879
- 3009340886
- 3013497507
- 3016450032
- 3014334038
- 3023657851
- 3022862651
- 3029082594
- 3005418651
- 3014908171
- 3005528784
- 2431166
- 9611283
- 8043752
- 9613083
- 3007597038
- 1417592
- 3012226300
- 3035708926
- 3017417635
- 3008770252
- 8030607
- 1056350
- 3008808082
- 3015895045
- 3003807268
- 3006380247
- 8010099
- 3011137372
- 3031564283
- 9616246
- 9615857
- 8043368
- 3004608878
- 3014586728
- 1123010
- 3010041511
- 3005440795
- 8040278
- 3003244954
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891269 | MICROTRAK EIA AUTOWASHER | Syva Co. | 1989-05-01 |
Legacy Summary#
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FDA Review#
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