BOUNDARY REINFORCED SINGLE-USE GOWNS
FDA 510(k) clearance K834339 · decided 1984-03-05
Clearance details
- K-number
- K834339
- Device name
- BOUNDARY REINFORCED SINGLE-USE GOWNS
- Applicant
- Procter & Gamble Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-12
- Decision date
- 1984-03-05
- Days to decision
- 84 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Procter & Gamble Mfg. Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.