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#
- 3008403546
- 3007389672
- 3023657851
- 9611112
- 3003322138
- 3005440795
- 3007507973
- 8010372
- 3004215117
- 3006410968
- 3005595283
- 2431166
- 9615857
- 9610617
- 3014313732
- 1223656
- 3006059835
- 1421879
- 1056350
- 3006098219
- 3005034064
- 3004892425
- 3003836856
- 3003761012
- 8040278
- 3002090132
- 8010099
- 3010041511
- 3035678069
- 3005536872
- 1923569
- 3010687973
- 3009465247
- 1937310
- 3014615697
- 3006487092
- 3008797953
- 3008338766
- 2242450
- 8040263
- 9681540
- 9611283
- 9613926
- 3015173212
- 3007597038
- 3004598675
- 8040881
- 3002806953
- 3004519921
- 3010399422
- 3003759558
- 1313525
- 3006142527
- 8040172
- 3001595398
- 3003244954
- 3010699884
- 8043816
- 3012507533
- 3010707607
- 3015895045
- 3009255580
- 8010523
- 8040179
- 3030410270
- 3002808270
- 3027556548
- 8010871
- 1032347
- 3001620590
- 3006380247
- 3032874372
- 3004168759
- 8010704
- 3003696170
- 3012267976
- 3015351976
- 8041151
- 1000426080
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 |