MASK, VAPOR, MONOMER
FDA 510(k) clearance K770690 · decided 1977-07-21
Clearance details
- K-number
- K770690
- Device name
- MASK, VAPOR, MONOMER
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-13
- Decision date
- 1977-07-21
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- JDY
- Device class
- 1
- Regulation number
- 888.4220
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CONTAIN(TM) LASER PLUME FILTER (K902167) | Arbor Technologies, Inc. | 1991-01-04 |
| LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER (K902056) | Hollister, Inc. | 1990-10-30 |
| CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 (K862509) | Lifestream Int'L, Inc. | 1986-07-23 |
| CEMENT FUME EVACUATOR TANK & FILTER (K810542) | Walgen Medical Innoventions | 1981-03-13 |
| BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (K790877) | Stackhouse Assoc. | 1979-05-23 |
| MONOMER EVACUATION SYSTEM (K780202) | Medishield, Inc. | 1978-02-21 |
| MONOMER VAPOR CONTAINMENT SYSTEM (K760906) | Howmedica Corp. | 1976-11-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |