510(k) K791681
- Device
- THE DENVER SPLINT
- Applicant
- XOMED, INC.
- 510(k) number
- K791681
- Product code
- EPP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-10-22
- Date received
- 1979-08-28
- Regulation
- 874.5800
- Classification name
- Splint, Nasal
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1318 Lonedell Rd. Arnold MO US 63010 63010
FDA Registration Numbers#
- 9613183
- 8010704
- 3023464160
- 3010951384
- 3013118873
- 1045254
- 3010202439
- 1037007
- 2020550
- 1417592
- 1928237
- 3010951382
- 1836161
- 3002858762
- 8040278
- 2024311
- 3010952189
- 3011050570
- 1220850
- 9613083
- 2029275
- 3008719017
- 3031218453
- 9613926
- 9612501
- 3018094310
- 1926681
- 3001644167
- 3010872396
- 3012494290
- 8030607
- 2027062
- 3021368823
- 1052728
- 3015337116
- 1825527
- 3003790304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EPP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Wfr/Aquaplast Corp. | 1994-07-29 |
| K942724 | EXTERNAL NASAL SPLINT | Micromed Development Corp. | 1994-07-08 |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Microbio-Medics, Inc. | 1989-12-08 |
| K890599 | HOOD NASAL SPLINT | Hood Laboratories | 1989-03-17 |
| K882244 | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | Richards Medical Co., Inc. | 1988-06-23 |
| K872905 | AMERICAN NASAL SPONGE | American Silk Sutures, Inc. | 1987-09-04 |
| K864930 | 'EXMOOR' ATKINS NASAL SPLINT | Exmoor Plastics , Ltd. | 1987-03-04 |
| K864932 | 'EXMOOR' CAWOOD NASAL SPLINTS | Exmoor Plastics , Ltd. | 1987-03-04 |
| K864933 | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | Exmoor Plastics , Ltd. | 1987-03-04 |
| K864934 | 'EXMOOR' SHAH SILICONE DISCS | Exmoor Plastics , Ltd. | 1987-01-28 |
| K863382 | CANNON NASAL SPLINT | Treace Medical, Inc. | 1986-10-07 |
| K862496 | MICROTEK INTRANASAL SPLINT | Microtek Medical, Inc. | 1986-07-14 |
| K810738 | GOODE MAGNETIC NASAL SPLINT | Xomed, Inc. | 1981-03-31 |
| K791053 | THE DENVER SPLINT | Ronald D. Shippert, M.D. | 1979-08-16 |
Legacy Summary#
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FDA Review#
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