Atlas FDA

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P

FDA 510(k) clearance K971108 · decided 1997-05-06

Clearance details

K-number
K971108
Device name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS721-P
Applicant
Alexander Mfg. Co.
Decision
Substantially Equivalent
Date received
1997-03-26
Decision date
1997-05-06
Days to decision
41 days
Clearance type
Traditional
Product code
MSG
Device class
2
Regulation number
886.1570
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Mason City, IA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Alexander Mfg. Co.

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

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.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY (K970268)Alexander Mfg. Co.1997-03-31

Recalls involving this device

No recalls on record reference this clearance.