510(k) K822201
- Device
- EAR CANNULAS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822201
- Product code
- FGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-10-06
- Date received
- 1982-07-23
- Regulation
- 878.4200
- Classification name
- Cannula, Injection
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3015821396
- 3034669683
- 1220592
- 3004957622
- 3004215117
- 1911916
- 8040278
- 3008812173
- 3010041511
- 3035678069
- 3010687973
- 3003477135
- 3016950436
- 3042250743
- 9710020
- 1063382
- 1313525
- 3036107253
- 2320762
- 3008785630
- 3013273457
- 1917413
- 3005273623
- 3002808270
- 3017509841
- 3003965134
- 1221435
- 1213809
- 1836161
- 1223925
- 3010419931
- 9613662
- 3035369854
- 1043214
- 8044098
- 3011526299
- 1820334
- 3005670221
- 3003915875
- 2618282
- 2027062
- 3005327291
- 9611503
- 3003418325
- 1423507
- 9616250
- 3011137372
- 1646747
- 2243072
- 3038632739
- 3007305485
- 3017352116
- 2246552
- 3001644167
- 3007648354
- 3008494033
- 3006389770
- 8020040
- 3012448339
- 3014615175
- 9610612
- 3014334038
- 1932180
- 3015542130
- 3005809810
- 8010273
- 3015140199
- 1211566
- 1423662
- 3008264111
- 1320894
- 3022320321
- 1220477
- 8030420
- 3004608878
- 3008513917
- 8030607
- 2183650
- 9680718
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FGY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760389 | CANNULA, IV | B. Braun Instruments | 1976-11-02 |
Legacy Summary#
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FDA Review#
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