510(k) K780723
- Device
- Otoscope Specula
- Applicant
- ABCO DEALERS, INC.
- 510(k) number
- K780723
- Product code
- EPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-09
- Date received
- 1978-05-02
- Regulation
- 878.1800
- Classification name
- Speculum, Ent
- 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#
- 3007597038
- 3013503739
- 3021680161
- 3005528784
- 3015351976
- 3004168759
- 9610905
- 3005739529
- 2246990
- 3003882387
- 1928237
- 3036795921
- 1037007
- 3011371465
- 8043368
- 3006487092
- 3005536872
- 3011050570
- 3005595283
- 8010482
- 3005440795
- 3001084743
- 3011310592
- 3033536312
- 3008936260
- 9614107
- 8043441
- 3004608878
- 3014342096
- 3007648354
- 3010726901
- 2242450
- 3012995405
- 3001644167
- 8043496
- 3003836856
- 9611112
- 9680519
- 2529846
- 3002834291
- 3009718267
- 9613083
- 1923569
- 3003032798
- 3005809810
- 3012226300
- 3030410270
- 3045853999
- 3009424883
- 3010829427
- 3006410968
- 8010372
- 3014313732
- 9610612
- 8010099
- 8010298
- 3003431869
- 3003694247
- 8030607
- 9680304
- 3035708926
- 3031564283
- 2434008
- 2085199
- 3001620590
- 1000426080
- 1032347
- 3004598675
- 3011137372
- 1055890
- 3014201171
- 3022763819
- 2648727
- 2084346
- 3003407244
- 3004571672
- 3003759558
- 1932180
- 8010665
- 1926681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EPY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950086 | PEDIA PALS, INCORPORATED | Pedia Pals, Inc. | 1995-02-07 |
| K925754 | ECONOM | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K853588 | FIBRELIGHT NASAL SPECULA | Downs Surgical , Ltd. | 1985-12-18 |
| K834189 | JAKOBI SURG. INSTRUMENTS #7 44/47 | Imm Enterprises , Ltd. | 1984-03-06 |
| K822370 | UNIVERSAL SPECULUM HOLDER | Treace Medical, Inc. | 1982-09-09 |
| K822373 | EAR SURGERY SPECULUM | Treace Medical, Inc. | 1982-09-09 |
| K822164 | EAR SPECULI | Kelleher Corp. | 1982-08-11 |
| K791123 | EAR AND NOSE SPECULA | Xomed, Inc. | 1979-07-10 |
| K772370 | BARRAQUER OVAL SPECULUM-VARIOUS SIZES | Edward Weck, Inc. | 1978-01-17 |
| K772380 | FARRIOR OVAL SPECULUM | Edward Weck, Inc. | 1978-01-17 |
| K772385 | THIN-BLADED NASAL SPECULUM | Edward Weck, Inc. | 1978-01-17 |