510(k) K770690
- Device
- MASK, VAPOR, MONOMER
- Applicant
- Howmedica Corp.
- 510(k) number
- K770690
- Product code
- JDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-21
- Date received
- 1977-04-13
- Regulation
- 888.4220
- Classification name
- Evacuator, Vapor, Cement Monomer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9615014
- 3007366790
- 9616671
- 1818910
- 8010379
- 3038503932
- 3027645317
- 1825034
- 9610921
- 3008110533
- 9617155
- 3008388427
- 3043088937
- 1020279
- 3043138885
- 1526350
- 3005180920
- 3013186738
- 1526534
- 1822565
- 3006406161
- 3010303097
- 3008744062
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JDY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Arbor Technologies, Inc. | 1991-01-04 |
| K902056 | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | Hollister, Inc. | 1990-10-30 |
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Lifestream Int'L, Inc. | 1986-07-23 |
| K810542 | CEMENT FUME EVACUATOR TANK & FILTER | Walgen Medical Innoventions | 1981-03-13 |
| K790877 | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | Stackhouse Assoc. | 1979-05-23 |
| K780202 | MONOMER EVACUATION SYSTEM | Medishield, Inc. | 1978-02-21 |
| K760906 | MONOMER VAPOR CONTAINMENT SYSTEM | Howmedica Corp. | 1976-11-11 |