PLASTIC MOUTH BARRIER HSV-I
FDA 510(k) clearance K853266 · decided 1985-10-29
Clearance details
- K-number
- K853266
- Device name
- PLASTIC MOUTH BARRIER HSV-I
- Applicant
- Westmark Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-05
- Decision date
- 1985-10-29
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- BYP
- Device class
- 1
- Regulation number
- 868.5620
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Skokie, 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 |
|---|---|---|
| NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (K955657) | North State Plastics, Inc. | 1996-03-12 |
| TRUZONE PFM DISPOSABLE MOUTHPIECE (K944512) | Monaghan Medical Corp. | 1994-11-02 |
| BREATHING MOUTHPIECE (K893791) | Diemolding Corp. | 1989-06-23 |
| AEROCHAMBER (K872037) | Monaghan Medical Corp. | 1987-07-24 |
| SAFE-T-SHIELD MOUTHPIECE (K865093) | Medi Nuclear Corp., Inc. | 1987-01-15 |
| INHALATION AID (K863049) | Boehringer Ingelheim Pharmaceuticals, Inc. | 1986-10-15 |
| MP-4400 MOUTHPIECE-FLANGE SEAL (K862788) | Medipart Jerry Alexander | 1986-08-01 |
| MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (K853572) | Medipart Jerry Alexander | 1985-10-29 |
| MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (K853574) | Medipart Jerry Alexander | 1985-10-29 |
| MEDIPART MOUTHPIECE MP-1010 (K853575) | Medipart Jerry Alexander | 1985-10-29 |
| E-Z-GUARD MOUTHPIECE (K853402) | E-Z-Em, Inc. | 1985-10-23 |
| IMPROVED MOUTHPIECE (K840459) | Kinetix | 1984-02-17 |
Recalls involving this device
No recalls on record reference this clearance.