BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
FDA 510(k) clearance K935835 · decided 1994-01-12
Clearance details
- K-number
- K935835
- Device name
- BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
- Applicant
- Busse Hospital Disposables, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-07
- Decision date
- 1994-01-12
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- BYX
- Device class
- 1
- Regulation number
- 868.5860
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hauppauge, NY, 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 |
|---|---|---|
| OXYGEN SUPPLY TUBING, MODEL 1115 (K011134) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| NORTH STATE PLASTICS AEROSOL TEE (K955656) | North State Plastics, Inc. | 1996-03-06 |
| GAS SAMPLING INTERFACES (K943110) | Coast Medical, Inc. | 1994-08-19 |
| MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (K931033) | Medical Fittings, Inc. | 1993-06-01 |
| MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (K931043) | Medical Fittings, Inc. | 1993-06-01 |
| OXYGEN TUBING, 81503 (K913422) | Specialty Packaging Producs, Inc. | 1992-01-30 |
| HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (K914980) | Medical Fittings, Inc. | 1992-01-21 |
| OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (K912763) | Medical Fittings, Inc. | 1991-10-15 |
| VARIOUS MALE QUICK CONNECTS. (K905091) | Medical Fittings, Inc. | 1991-03-04 |
| SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (K905094) | Medical Fittings, Inc. | 1990-11-20 |
| OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS (K904757) | Medical Fittings, Inc. | 1990-10-31 |
| MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS (K904702) | Medical Fittings, Inc. | 1990-10-31 |
Recalls involving this device
No recalls on record reference this clearance.