BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER— 510(k) K032432
Substantially EquivalentBusse Hospital Disposables, Inc.
FDA 510(k) clearance K032432 for BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER, Substantially Equivalent on 2003-08-28. Applicant: Busse Hospital Disposables, Inc.. Device class: 2.
Clearance details
- Applicant
- Busse Hospital Disposables, Inc.
- Product code
- Code FMJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2500
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntington, CT, US
Recent devices under product code FMJ
view allMore clearances from Busse Hospital Disposables, Inc.
view allRecalls naming K032432
K-number listed on FDA's recall record- Z-0540-2018 — Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
- Z-0541-2018 — Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
- Z-0542-2018 — Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
- Z-0543-2018 — Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
- Z-0544-2018 — Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
- Z-0545-2018 — Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
- Z-0546-2018 — Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032432.
Data sourced from openFDA. This site is unofficial and independent of the FDA.